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| ORIGINAL ARTICLE |
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| Year : 2015 | Volume
: 13
| Issue : 1 | Page : 4-10 |
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The effect of the dentifrice on gingivitis and dental plaque: A 6-week clinical study in India
K. V. V. Prasad1, I Anupama1, N Rao1, PK Sreenivasan2, R Subramanyam2, RD Kulkarni3
1 Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital, Bengaluru, Karnataka, India
2 Department of Oral Health Research, Colgate Palmolive Company, Piscataway, New Jersey, USA
3 Department of Microbiology, SDM College of Medical Sciences and Hospital, Bengaluru, Karnataka, India
| Date of Web Publication | 19-Mar-2015 |
Correspondence Address:
Dr. K. V. V. Prasad
Department of Public Health Dentistry, SDM College of Dental Sciences, Dharwad - 580 009, Karnataka
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2319-5932.153548
Introduction: Dentifrices are commonly used for oral hygiene with some formulated with antimicrobial agents to control plaque. There is little information regarding the effects of dentifrices on controlling dental plaque and gingivitis amongst Indian subjects. Objective: To evaluate the efficacy of three commercially-available fluoride dentifrices on established gingivitis and supragingival dental plaque after 6-week of product use. Materials and Methods: Adult subjects completing informed consent and presenting a Loe-Silness gingival index (GI) score ≥ 1.0 and a Quigley-Hein, Turesky Modification, plaque index (PI) score ≥ 1.5 completed a 2-week washout period with commercial fluoride toothpaste. They were instructed to refrain from all other oral hygiene products (including mints, chewing gums, mouth rinses). Subjects returned to the clinical facility again having refrained from all oral hygiene procedures for 12 h and from eating, drinking or smoking for 4 h for baseline gingivitis and plaque examinations. They were randomly assigned to one of three treatment groups according to baseline gingival and plaque indices scores: (1) A dentifrice containing 0.3% triclosan and 1000 ppm sodium monofluorophosphate (Colgate ® Supershakti Dental Cream), (2) a dentifrice containing 0.54% zinc citrate, 0.64% stannous chloride and 0.33% sodium fluoride (Crest ® Pro-Health All Good 7 Effects Toothpaste), and (3) a dentifrice containing 1000 ppm sodium monofluorophosphate (Colgate ® CIBACA Toothpaste [negative control]). After 6-week use of their assigned dentifrice, all subjects were recalled for posttreatment plaque and GI examinations. Results: 105 subjects completed the study. Baseline plaque and GI scores demonstrated no statistical differences between treatment groups (P > 0.05). Further, Chi-square analysis demonstrated no significant differences between treatment groups for subject age or gender (P > 0.05). At the 6-week examinations, subjects in all three dentifrice groups exhibited statistically significant reductions in GI scores (32.5%, 16.6% and 19.9%, respectively) and PI (38.1%, 16.4% and 20.4%, respectively) scores from baseline (P < 0.05). The triclosan group exhibited statistically significant (P < 0.05) reductions in GI scores (17.5% and 12.5%, respectively) and PI scores (21.7% and 19.1%, respectively) when compared to the zinc citrate/stannous chloride dentifrice and to the sodium monofluorophosphate dentifrice. Conclusion: The triclosan/sodium monofluorophosphate dentifrice (Colgate Supershakti Dental Cream) demonstrated significantly less gingivitis and greater reductions of supragingival dental plaque (P < 0.05) when compared to a dentifrice containing zinc citrate/stannous chloride/sodium fluoride (Crest Pro-Health All Good 7 Effects Toothpaste) and to a dentifrice containing sodium monofluorophosphate (Colgate CIBACA Toothpaste). Keywords: Dentifrice, gingivitis, plaque, triclosan
How to cite this article:
Prasad K, Anupama I, Rao N, Sreenivasan P K, Subramanyam R, Kulkarni R D. The effect of the dentifrice on gingivitis and dental plaque: A 6-week clinical study in India. J Indian Assoc Public Health Dent 2015;13:4-10 |
| Introduction | |  |
Periodontal disease has been known to affect mankind since the beginning of recorded history, and even today remains an oral health problem worldwide. It is a condition wherein, inflammation and infection destroy the supporting structures of the teeth, including the gingiva, the periodontal ligament and the alveolar bone. Gingivitis, the mildest form of periodontal disease, is an inflammatory process confined to the gingiva. It is caused by a nonspecific, long-term accumulation of plaque on the teeth and is usually reversible. Plaque-induced gingivitis is the most common form of periodontal disease. [1]
There is ample evidence to implicate dental plaque as the primary etiological agent response for inflammatory gingival and periodontal disease. [2] Clinical studies conducted in the mid-20 th century first documented the cause and effect relationship between plaque accumulation and the development of gingivitis in humans. [3],[4] Plaque is a biofilm that develops on the hard tissue, primarily enamel, and consists of bacteria, mucus, extracellular matrix and fluid channels. [5],[6] Plaque acts as a reservoir for bacteria. Left alone, plaque will eventually inflame the gingiva that results in infection. This infection leads to gingivitis, generally described as gingival inflammation in the absence of clinical attachment loss or the presence of reduced but stable attachment levels, and could eventually lead to periodontitis, described as the presence of gingival inflammation at sites where there has been apical migration of the epithelium onto the root surface with the concomitant loss of connective tissue and alveolar bone. [6],[7],[8],[9]
Daily home care is an important element of oral health. However, even with effective tooth cleaning, bacteria colonize the tooth surface, and the developing biofilm (plaque) releases a variety of biologically active products that diffuse into the gingival epithelium to initiate the host response that eventually results in gingivitis. [10] More recent research strongly suggests that the oral inflammation caused by the bacteria living in the dental plaque may contribute to various systemic diseases, including diabetes, coronary heart disease, peripheral arterial disease, cardiovascular disease, ischemic stroke, low birth weight, preterm babies and osteoporosis. [11],[12]
It is undisputed that people do not consistently perform home oral care procedures at an acceptable level. [12] As such, oral health researchers have looked for compounds which when incorporated into dentifrices provide clinically proven antiplaque and antigingivitis benefits. One such compound that has been shown in a multitude of clinical studies to have these benefits is triclosan. It is a bisphenolic antibacterial agent, which has low toxicity and a broad spectrum of activity, being effective against both Gram-positive and Gram-negative bacteria. [13],[14] Triclosan has been shown to be compatible with oral hygiene product ingredients and safe for consumer use. [14],[15],[16],[17],[18],[19]
Objective
To compare the effects of brushing with a commercially available dentifrice containing triclosan (Colgate Supershakti Dental Cream) to brushing with a dentifrice containing zinc citrate and stannous chloride (Crest Pro-Health All Good 7 Effects Toothpaste) and Colgate ® CIBACA Toothpaste, Colgate-Palmolive Company, India), over a 6-week period on established gingivitis and supragingival dental plaque.
| Materials and Methods | | |
This independent clinical study employed a double-blind, stratified, three treatment parallel-group study design, conducted at the Department of Public health Dentistry, SDM College of Dental Sciences and Hospital, Dharwad, India The protocol for this study was reviewed and approved by an independent Institutional Review Board.
Adult male and female subjects from North West Karnataka, India were enrolled into the study based upon the following criteria:
Subjects:
- Had to be between the ages of 18 and 70 (inclusive), in generally good health and had to have signed an Informed Consent form
- Had to be available for the duration of the study
- Had to possess at least 20 uncrowned permanent natural teeth (excluding third molars)
- With plaque index (PI) scores ≥1.5 according to the Quigley-Hein PI scoring procedure and a gingival index (GI) score ≥1.0
- Had to perform adequate oral hygiene with no signs of oral neglect, good periodontal health and no >5 periodontal pockets of 5 mm.
Subjects were excluded if:
- They had five or more decayed untreated dental sites at screening, other disease of the hard or soft oral tissues, impaired salivary function, were immune compromised individuals (HIV, AIDS, immune suppressive drug therapy)
- They had taken medications that could affect the study outcome, including but not limited to certain antibiotics or antimicrobial drugs, within 1-month prior to the start of the study or while participating in the study
- They were pregnant or lactating women
- Individuals who were participating in any other clinical study or who had participated in a study within 1-month prior to enrollment
- They presented orthodontic bands; or partial or removable dentures; or received a dental prophylaxis anytime during the 2-week prior to the first dental examination or had a history of alcohol or drug abuse
- They had a history of allergies to the test products, or allergies to oral care/personal care consumer products or their ingredients, or subjects with existing medical conditions, which prohibits them from eating and drinking for periods up to 4 h
- They had used a triclosan-containing dentifrice up to 3 months prior to the start of the study.
Methods
Prospective study subjects reported to the clinical facility having refrained from all oral hygiene procedures for 12 h and from eating, drinking or smoking for 4 h prior to their screening visit. Subjects who met the inclusion/exclusion criteria, presented a normal oral soft and hard tissue assessment and a GI score ≥ 1.0 and a PI score ≥ 1.5 received a commercially-available fluoride dentifrice and a soft bristled toothbrush and were instructed to use only these products with no other oral hygiene products (mints, chewing gums, mouth rinses, etc.,) for a 2-week washout phase. Subjects reported back to the clinical facility having refrained from all oral hygiene procedures for 12 h and from eating, drinking or smoking for 4 h to have a baseline assessment of oral soft and hard tissues and baseline gingival and plaque examinations. Subjects received a demonstration of the brushing technique and were asked to brush for a minimum of 1 min.
Subjects were randomly assigned to one of the three treatment groups according to baseline gingival and PI scores. The first three received one each of the three pastes, the next few were given the products after randomizing their plaque and gingivitis scores on the excel sheet, keeping a tally of means and standard deviations.
Treatment groups
- A dentifrice containing 0.3% triclosan and 1000 ppm fluoride as sodium monofluorophosphate (marketed as Colgate ® Supershakti Dental Cream, Colgate-Palmolive Company, India)
- A dentifrice containing 0.54% zinc citrate, 0.64% stannous chloride and 0.33% sodium fluoride (marketed as Crest ® Pro-Health All Good 7 Effects Toothpaste, Procter and Gamble Company, China)
- A dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (marketed as Colgate ® CIBACA Toothpaste, Colgate-Palmolive Company, India).
Subjects were provided with a soft-bristle toothbrush and their assigned dentifrice that was over-wrapped in its original package to maintain the double-blind study design. Subjects were instructed to brush their teeth with their assigned toothpaste and toothbrush twice daily (morning and evening) for 1 min, and to use only the toothpaste and toothbrush provided. After 6-week, subjects reported to the clinical facility after refraining from oral hygiene for a 12 h period and from eating, drinking and smoking for 4 h where they received an oral hard and tissue assessment and a gingival and plaque examination. A visit form was completed for each subject during every visit and was used to determine if there was reason to exclude subject from continuing in the study or to exclude the data from statistical analysis.
Clinical scoring procedures
Gingivitis was scored according to the Loe and Silness GI [20] as modified by Talbott et al.[21] Supragingival dental plaque was scored according to the Turesky Modified Quigley-Hein PI to determine the presence or absence of supragingival plaque. [22],[23]
Third molars and teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Whole-mouth mean scores were obtained by averaging the values recorded overall scorable tooth surfaces in the mouth.
The dental examiner visually examined the oral cavity and peri-oral area using a dental light and dental mirror. This examination included an evaluation of the soft and hard palate, gingival mucosa, buccal mucosa, mucogingival fold areas, tongue, sublingual and submandibular areas, salivary glands and the tonsilar and pharyngeal areas.
Adverse events were obtained from an interview with the subjects and from a dental examination by the examining dentist.
Statistical analyses
Statistical analyses were performed separately for the gingivitis assessments and supragingival plaque assessments. Comparison of the treatment groups with respect to gender were performed using a Chi-square analysis and for age an independent t-test. Comparisons of the treatment groups with respect to baseline GI scores and PI scores were performed using an analysis of variance. Within-treatment comparisons of the baseline versus 6-week GI scores and PI scores were performed using paired t-test. Comparisons of the treatment groups with respect to baseline-adjusted GI scores and PI scores at the 6-week examinations were performed using analyses of covariance (ANCOVA's). Post-ANCOVA pair-wise comparisons of the study treatments were performed using the Tukey's test for multiple comparisons. All statistical tests of hypotheses were two-sided, and employed a level of significance of α =0.05.
| Results | | |
One hundred and twenty was the estimated sample size with 40 individuals in each group. Following a baseline examination, assuming an occurrence of dropouts owing to migration, unforeseen health events and other reasons, 120 individuals were recruited. Out of 120, 105 subjects entered the clinical study, complied with the protocol and completed the 6-week clinical study. A summary of the gender and age of the study groups is presented in [Table 1]. The treatment groups did not differ significantly with respect to either of these characteristics.
Baseline data
The mean baseline GI scores were 1.46 for the triclosan/sodium monofluorophosphate dentifrice group, 1.51 for the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 1.54 for the sodium monofluorophosphate dentifrice group. The mean baseline PI scores were 2.30 for the triclosan/sodium monofluorophosphate dentifrice group, 2.26 for the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 2.39 for the sodium monofluorophosphate dentifrice group. No statistically significant differences were observed among the treatment groups with respect to GI or PI scores at baseline [Table 2]. | Table 2: Baseline gingival index and plaque index scores of the study subjects
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Six weeks data
Gingivitis
[Table 3] presents a summary of the GI scores measured after 6-week of product use. | Table 3: Gingival index scores of the study subjects after 6-week clinical study
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Six weeks versus baseline
The mean 6-week GI scores were 1.17 for subjects in the triclosan/sodium monofluorophosphate dentifrice group, 1.26 for subjects in the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 1.04 for subjects in the sodium monofluorophosphate dentifrice group. The mean percent reductions from baseline were 32.5% for subjects in the triclosan/sodium monofluorophosphate dentifrice group, 19.9% for subjects in the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 16.6% for subjects in the sodium monofluorophosphate dentifrice group, all being statistically significant (P < 0.05).
Comparison between treatment groups
When compared to subjects in both the zinc citrate/stannous fluoride/sodium fluoride dentifrice group and sodium monofluorophosate dentifrice group, the triclosan/sodium monofluorophosphate dentifrice group exhibited statistically significant (P < 0.05) reductions of 17.5% and 12.5% respectively in GI scores after 6-week of product use. The sodium monofluorophosphate dentifrice group exhibited a 7.1% nonstatistically significant reduction (P > 0.05) in GI scores when compared to the zinc/citrate/stannous fluoride/sodium fluoride dentifrice group.
Plaque
[Table 4] presents a summary of the PI scores measured after 6-week of product use. | Table 4: Plaque index scores of the study subjects after 6-week clinical study
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Six weeks versus baseline: The mean 6-week PI scores were 1.48 for subjects in the triclosan/sodium monofluorophosphate dentifrice group, 1.89 for subjects in the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 1.83 for subjects in the sodium monofluorophosphate dentifrice group. The mean percent reductions from baseline were 38.1% for subjects in the triclosan/sodium monofluorophosphate dentifrice group, 16.4% for subjects in the zinc citrate/stannous chloride/sodium fluoride dentifrice group and 20.4% for subjects in the sodium monofluorophosphate dentifrice group, all being statistically significant (P < 0.05).
Comparison between treatment groups: Compared to subjects in both the zinc citrate/stannous fluoride/sodium fluoride dentifrice group and the sodium monofluorophosate dentifrice group, the triclosan/sodium monofluorophosphate dentifrice group exhibited statistically significant (P < 0.05) reductions of 21.7% and 19.1% respectively, in PI scores after 6-week of product use. The sodium monofluorophosphate dentifrice group exhibited a 3.2% nonstatistically significant reduction (P > 0.05) in PI scores when compared to the zinc/citrate/stannous fluoride/sodium fluoride dentifrice group.
Adverse events
Throughout the study, there were no adverse events on the oral soft and hard tissue of the oral cavity observed by the examiner, or reported by the subjects when questioned.
| Discussion | | |
Plaque control is the foundation of any attempt to prevent and control periodontal disease. It is well accepted that most people fail to achieve a level of oral hygiene commensurate with periodontal health. [24],[25] Periodontal disease is initiated by plaque bacteria, and oral health focus has centered on the possibility of enhancing oral hygiene by incorporating chemotherapeutic agents into dentifrices formulations. Agents that, among others, have been shown to have antiplaque properties are triclosan, stannous salts, and zinc salts. This double-blind clinical study provided an investigative comparison of the clinical efficacy of three commercially-available dentifrices marketed in India with respect to the reduction of gingivitis and supragingival dental plaque over a 6-week period. One dentifrice, Colgate Supershakti Dental Cream contains 0.3% triclosan and 1000 ppm sodium monofluorophosphate. The second dentifrice, Crest Pro-Health All Good 7 Effects Toothpaste contains 0.54% zinc citrate/0.64% stannous chloride/0.33% sodium fluoride. The negative control dentifrice is a commercially available 1000 ppm sodium monofluorophosphate dentifrice (Colgate CIBACA Toothpaste).
Triclosan, alone and in combination with a Polyvinyl methyl ether/maleic acid (PVM/MA) copolymer, has consistently shown antigingivitis and antiplaque efficacy in numerous clinical studies. [26],[27],[28],[29] Triclosan, a phenolic antibacterial and anti-inflammatory agent with low toxicity and a broad spectrum of activity, has been shown to be effective against Gram-positive and Gram-negative bacteria. The stannous chemistry is complex as several species form upon hydration of stannous fluoride or its reaction with dental hard tissue. Due to the reactive nature of the tin (II) ion, it has to be stabilized in a formulation to prevent it from being oxidized and consequently becoming insoluble and ineffective. [30],[31] Stannous salts require low pH formulations and the presence of gluconate and/or olaflur (amine fluoride) that act as chelators for optimum stability. Combining stannous fluoride and stannous chloride into dentifrice formulations has been a way to increase stannous concentration since the amount of stannous from stannous fluoride is limited by regulated fluoride concentrations. Zinc salts have been combined with stannous salts or used alone. The two most used zinc salts are citrate and chloride, both shown to have some antiplaque efficacy. [32],[33]
This clinical study at the 6-week examinations showed that all the subjects in the triclosan/sodium monofluorophosphate dentifrice group, zinc citrate/stannous fluoride/sodium fluoride dentifrice group, and sodium monofluorophosphate dentifrice group exhibited statistically significant (P < 0.05) reductions (19.9%, 32.5% and 16.6% respectively) from baseline with respect to GI scores. In addition, all the subjects in the triclosan/sodium monofluorophosphate dentifrice group, zinc citrate/stannous fluoride/sodium fluoride dentifrice group, and sodium monofluorophosphate dentifrice group exhibited statistically significant (P < 0.05) reductions (38.1%, 16.4% and 20.4% respectively) from baseline with respect to PI scores.
The results of this study showed that after 6-week of twice daily tooth brushing, subjects using the triclosan/sodium monofluorophosphate dentifrice exhibited statistically significant (P < 0.05) reductions (17.5% and 12.5% respectively) in GI scores when compared to subjects in both the zinc citrate/stannous chloride/sodium fluoride dentifrice and the sodium monofluorophosphate dentifrice groups.
Also at the 6-week examinations, subjects in the triclosan/sodium monofluorophosphate dentifrice group exhibited statistically significant (P < 0.05) reductions (21.7% and 19.1% respectively) in PI scores when compared to subjects in both the zinc citrate/stannous fluoride/sodium fluoride dentifrice and the sodium monofluorophosphate dentifrice groups.
Limitations and recommendations
This was a 6-week study with evaluations conducted at baseline and 6-week use of an assigned test toothpaste. Presented in the literature are studies of longer duration that offer additional insights on the effects of toothpastes on maintaining dental plaque and gingival status. Based on the present results, future efforts evaluating longer term effects can be proposed.
| Conclusion | | |
The results of this double-blind clinical study support that the commercially available dentifrice containing 0.3% triclosan and 1000 ppm sodium monofluorophosphate (COLGATE SUPERSHAKTI Dental Cream), a commercially available dentifrice containing 0.54% zinc citrate, 0.64% stannous chloride and 0.43% sodium fluoride (CREST PRO-HEALTH All Good 7 Effects Toothpaste), and a commercially available 1000 ppm sodium monofluorophosphate dentifrice (COLGATE CIBACA Toothpaste) provided statistically significant reductions (P < 0.05) in gingivitis and supragingival dental plaque after 6-week of product use.
The results also support the that a commercially available dentifrice containing 0.3% triclosan and 1000 ppm sodium monofluorophosphate (COLGATE SUPERSHAKTI Dental Cream) provided statistically significant greater reductions (P < 0.05) in gingivitis and supragingival dental plaque when compared to the CREST PRO-HEALTH All Good 7 Effects Toothpaste (0.54% zinc citrate, 0.64% stannous chloride, 0.43% sodium fluoride) and the COLGATE CIBACA Toothpaste (1000 ppm sodium monofluorophosphate).
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[Table 1], [Table 2], [Table 3], [Table 4]
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