|Year : 2022 | Volume
| Issue : 1 | Page : 95-99
Efficacy of ozone oil compared with chlorhexidine gluconate gel (1% w/w) for the treatment of gingivitis: Randomized controlled trial
Mahima B Bulani, Sahana Hegde Shetiya, Deepti Agarwal
Department of Public Health Dentistry, Dr.D Y Patil Dental College and Hospital, Dr.D Y Patil Vidyapeeth, Pimpri, Pune, Maharashtra, India
|Date of Submission||07-May-2021|
|Date of Decision||31-Aug-2021|
|Date of Acceptance||29-Dec-2021|
|Date of Web Publication||25-Feb-2022|
Sahana Hegde Shetiya
Department of Public Health Dentistry, Dr. D.Y Patil Vidyapeeth Pune, Dr. D.Y.Patil Dental College and Hospital, Pimpri, Pune - 411 018, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Ozone oil has both antimicrobial and antiinflammatory properties. This study was undertaken to compare the efficacy of ozone oil with chlorhexidine gluconate 1.0% w/w gel for the treatment of gingivitis. Methods: A triple-blind, controlled trial with parallel design was conducted for 28 days as a pilot study. Thirty participants aged 14–17 years were recruited. After baseline data collection involving gingival index (GI) and plaque index (PI), the products were distributed, scaling of teeth was done, and oral hygiene instructions were given. The participants were asked to apply the gel and oil topically and followed up on days 7 and 28. Results: A statistically significant difference (P < 0.01) was seen within the ozone and chlorhexidine groups at the end of 28 days, showing a reduction in the plaque and gingival scores. At day 28, the reduction in plaque and gingival score was significant for the chlorhexidine group. It was found that chlorhexidine gel showed a greater reduction in the clinical parameters than the ozone oil, which was statistically significant but clinically similar. Both the products showed a substantial reduction in plaque scores. The participants from both the groups showed an improvement, having mild gingivitis post intervention. Conclusion: Ozone oil showed a significant reduction in the clinical parameters of PI and GI similar to chlorhexidine gel, thereby signifying its antimicrobial and antiinflammatory effects on the gingival tissues without any adverse effects, implicating the possession of properties required by a chemotherapeutic agent.
Keywords: Chlorhexidine, dental plaque, gingivitis, ozone oil
|How to cite this article:|
Bulani MB, Shetiya SH, Agarwal D. Efficacy of ozone oil compared with chlorhexidine gluconate gel (1% w/w) for the treatment of gingivitis: Randomized controlled trial. J Indian Assoc Public Health Dent 2022;20:95-9
| Introduction|| |
Gingivitis is inflammation of the gums, which is chronic. Inflammation and ulceration of the sulcular epithelium occurs due to the presence of microorganisms which are attached to the tooth in and near the gingival sulcus in the form of plaque. The association between dental plaque and gingivitis has been well established. Dental plaque associated with gingivitis may comprise Gram-positive and Gram-negative microorganisms, facultative anaerobes, spirochetes, and motile rods, suggesting nonspecific hypothesis for occurrence of gingivitis, indicating initiation of gingival inflammation by the presence of many bacterial species in high numbers due to inadequate oral hygiene. Redness, bleeding on probing, variation in gingival contour, loss of stippling, edema, and soft and friable consistency of gingiva are the signs of gingivitis. Progression of gingivitis to periodontitis is possible through effective plaque control on a day-to-day basis.
Chemical plaque control by chlorhexidine is well known. However, it has been found to have side effects of staining of teeth, altered taste sensation, and mucosal desquamation. Recently, it has been found that ozone which is triatomic oxygen and an unstable gas can be used in dentistry. Ozone acts as an antimicrobial agent by modification of intracellular contents and lysis of the dual bonds through damage of the cytoplasmic membranes of the cells. Its anti-hypoxic effect improves metabolism of the inflamed tissues, thereby reducing the inflammatory process. Inflammation reduction and promotion of healing is possible through the synthesis of biologically active substances such as interleukins, leukotrienes, and prostaglandins.
Ozone is available in the form of oil, water, and gas. Ozone oil is composed of vegetable oils (sunflower oil and sesame oil) which is ozonized for 100 h at 100 g/h. It has been found to have an antiseptic activity due to the release of peroxides bringing about oxidation of microorganisms. Ozone present in oily vehicle provides prolonged tissue surface contact and allows storage for several months, serving as an advantage over ozone in gaseous form, which is ephemeral and ozone water which has to be freshly prepared each time.
The anti-inflammatory and antimicrobial actions have helped in the treatment of acute necrotizing ulcerative gingivitis (ANUG) and exophytic fibrous gingival lesion. An in vitro study has already been conducted to compare the antimicrobial efficacy of ozone oil with chlorhexidine where it was found that ozone oil had better antimicrobial properties than chlorhexidine. As per the specifications by the American Dental Association, a chemotherapeutic agent for the treatment of gingivitis should possess both antimicrobial and anti-inflammatory properties, which were found to be possessed by ozone oil (Ozonil®, Ozone Forum of India, Mumbai, Maharashtra, India). Hence, this study was undertaken to compare the efficacy of ozone oil with chlorhexidine (Hexigel®, ICPA Health Products Limited, India) for the treatment of gingivitis with antiplaque role as a primary objective and antigingivitis role as a secondary objective. The null hypothesis states that there is no difference between ozone oil and chlorhexidine as an anti-inflammatory agent.
| Materials and Methods|| |
The study participants were 14- to 17-year-old male children residing at homes for indigent children, Pune, situated 6 km apart from each other and were chosen based on convenience keeping in mind the avoidance of contamination between the groups. Verbal and written consent was obtained from every participant and from their parents prior to the commencement of the study. Ethical approval was obtained from the Institutional Ethics Committee of the dental college (IEC/DYPDCH/PHD-TD/03). The examiner was trained and calibrated at the department of public health dentistry by an expert examiner for plaque index (PI) and gingival index (GI) with interexaminer reliability ranging from 0.78 to 0.94 using intraclass correlation. The pilot study (an educated guess was made for sample size estimation) conducted in August 2015 comprised systemically healthy thirty participants having at least twenty permanent teeth and satisfying the inclusion criteria of having moderate-to-severe gingivitis (score of 1.1–3) using GI with absence of crowding in dentition and not on antibiotic therapy prior to 1 month of screening and with no history of systemic illness. The study was a triple-blinded controlled trial with parallel design with 1:1 allocation ratio conducted for a period of 28 days with preparatory period of 7 days and interventional period of 21 days. The participants and the examiner who was also the analyzer were blinded. The trade names and contents of both the products were masked using a masking tape. On day 0, dental check up and treatment through mobile dental clinic was arranged at both the homes for indigent children. Fifteen participants from each home satisfying the inclusion criteria were randomly selected using a computer-generated random number of tables. Then, scaling was done for all the thirty study participants. Toothpastes and toothbrushes were distributed to the participants, and toothbrushing technique was demonstrated for the standardization of oral hygiene procedures. Oral hygiene instructions were given to rinse their mouth after every meal. They were instructed not to use any other mouthrinse or gel during the study period (28 days).
On day 7, demographic data were recorded using a structured pro forma where the plaque and gingival status were assessed using GI by Loe and Silness and Modified Quigely Hein PI by Turesky et al. front or side of the participant for examination. Examination was done using a pen light torch. The recording clerk was trained to write the scores on the pro formas as told by the investigator. Instructions were given to the children and caretakers regarding the use of the products. The study group participants were instructed to topically apply ozone oil as the intervention and the control group participants were instructed to topically apply chlorhexidine gel twice a day after half an hour of toothbrushing in the morning and at night for 21 days. The test and control products were randomly distributed in two separate identical boxes by a colleague using the toss of coin method for randomization at the homes for indigent children (i.e., test product at one home and control product at other home), thereby concealing the allocation prior to assignment. On day 28, clinical examinations were conducted to assess the outcome and plaque and gingival status of all the participants. The baseline and final clinical parameters of all the participants were recorded during the morning hours of the day, i.e., 3 h after their breakfast. Duplicate examination was conducted on five participants in each group (ozone oil and chlorhexidine gel group) while collecting baseline and final plaque and gingival scores which ranged from 0.85 to 0.92. Data were compiled, and normality was tested using Levene's test. Intergroup comparisons were made using unpaired t-test, whereas intragroup comparisons were made using paired t-test. P < 0.05 was considered statistically significant.
| Results|| |
A total of thirty participants aged 14–17 years were recruited in this study whereby 15 each were assigned to the ozone oil group and chlorhexidine gel group in August 2015. All were able to complete the 28 days' trial [Flow Diagram 1].
- At baseline (day 7)
Patients in both ozone oil group (test group) and chlorhexidine gel group (control group) were found to have higher PI and GI scores at the baseline. In addition, there was no statistically significant difference in the PI and GI scores between both the groups (P > 0.05) [Table 1].
|Table 1: Comparison of gingival index and plaque index in ozone group and chlorhexidine group|
Click here to view
- At follow-up (day 28)
- Intragroup comparisons of clinical parameters
There was a significant reduction in PI (P = 0.00) and GI (P = 0.00) from baseline scores to final scores in both the groups.
- Intergroup comparisons of clinical parameters
There was a greater reduction from baseline to follow-up in both PI (P = 0.002) and GI (P = 0.00) scores in the chlorhexidine gel group when compared to the ozone oil group, which was found to be statistically significant.
Ozone oil was found to have good patient acceptance and did not show any adverse reactions.
| Discussion|| |
Plaque is one of the main etiological agents leading to gingival and periodontal diseases. The disruption of plaque is necessary for the prevention of gingival and periodontal diseases. There is a need for chemotherapeutic agents as the adult population is unable to perform mechanical tooth cleaning adequately. A chemotherapeutic agent for treatment of gingivitis should possess both antimicrobial and anti-inflammatory effects. A study by Ruiz et al. found ozone oil to be effective against gingival inflammation, pain, and gingival bleeding for the treatment of ANUG without any adverse effects, suggesting its anti-inflammatory effect and safety profile for oral tissues. The antimicrobial effectiveness of ozone oil was found to be greater than that of chlorhexidine and povidone–iodine against the bacterial strains of Staphylococcus aureus and Porphyromonas gingivalis in an in vitro study. Hence, the antimicrobial and anti-inflammatory effects of ozone oil as a chemotherapeutic agent for the treatment of gingivitis were assessed in this study.
It was a triple-blind, controlled trial with participants and the investigator who was also the analyzer being blinded. The study was conducted at homes for indigent children which were six km apart, thereby preventing contamination of participants. Convenience sampling technique was used. Sample size was not calculated as there was no prior study where ozone oil had been used for the treatment of gingivitis. Hence, this study has been considered to be a pilot study where 15 participants each were allotted to the test and control groups.
It was a 28-day preventive trial following the recommendations of Chilton and Fleiss to undertake trials regarding gingival inflammation. There was a preparatory period of 7 days whereby initial scaling was done for all the participants to establish similar baseline scores. Then, the baseline clinical parameters were recorded on day 7 to allow gingival healing by restoration and epithelialization of gingival sulcular and junctional epithelium, which generally requires 2 to 7 days, and also obtain realistic and objective levels of plaque and gingival health. An interventional period of 21 days was undertaken as plaque formation becomes relatively stable by this time., The participants were advised topical application of the products half an hour after toothbrushing to avoid interaction with anionic surfactants of the toothpaste. Compliance of the participants was checked by a colleague (AB) who distributed the products through timely communication with the supervisor of the participants and assessing the quantity of product used.
The antiplaque/antimicrobial action of both the products was assessed using the Turesky–Gilmore–Glickman modification of Quigley-Hein PI, 1970 as it enables a more objective evaluation of plaque by using a disclosing agent and also takes the assessment of the coronal extent of plaque into consideration. The anti-inflammatory action was assessed using the GI which assesses the severity of gingivitis based on the qualitative changes of gingival soft tissues. It is a sensitive index which allows objective evaluation by using periodontal probe for assessment.
The results of this study revealed that there was a significant reduction in gingival and plaque scores in both the groups from baseline, indicating that ozone oil also has antiplaque and anti-inflammatory actions like chlorhexidine gel and thus possesses the properties of a chemotherapeutic agent for the treatment of gingivitis. Similar results of reduction in clinical parameters of PI, bleeding on probing, probing pocket depth, gingival recession, and clinical attachment loss were found in a study where ozone water was used as an adjunct to scaling and root planing (SRP) in chronic periodontitis. However, the reduction was similar to the control group which used distilled water adjunctively to SRP. A study revealed reduction in PI, GI, and bleeding indices with ozone water irrigation when compared to chlorhexidine for the treatment of chronic periodontitis. A study revealed healing of mucosal lesions using ozone oil occurring due to bisphosphonate-induced osteonecrosis of jaw without any adverse effects. Epithelial healing and gingival health is better when superficial indices are applied along with improvement in keratinization as seen in cytological analysis when ozonated oil is applied topically on grafted gingival wounds and palatal donor sites. Indukar and Verma also reported significant reduction in plaque and gingival scores when ozonated oil was rubbed over the gingiva. A significant reduction was also found with Verma et al.'s. study which used similar methodology. However, one of the studies found that SRP followed by ozonotherapy in gaseous form did not report any improvement of clinical parameters in chronic and aggressive periodontitis.
In this study, it was found that chlorhexidine gel showed a greater reduction in the clinical parameters than the ozone oil, which was statistically significant but clinically similar. The results were in contrast to the study wherein ozone oil and chlorhexidine showed no significant difference in reduction of plaque and gingival scores. Another study supported this dissimilarity and reported no statistical and clinical significant difference in plaque and gingival scores between the use of ozone oil and chlorhexidine. Both the products showed a substantial reduction in plaque scores. The participants of both the groups showed an improvement in severity of gingivitis which reduced from severe-to-moderate gingivitis at baseline (prior to the intervention) to mild form of gingivitis post intervention. Thus, ozone oil also showed an improvement in both the clinical parameters similar to chlorhexidine gel with no adverse effects, suggesting that it may be used as a chemotherapeutic agent for the treatment for gingivitis.
As no study has been found where ozone oil had been used as a chemotherapeutic agent for the treatment of gingivitis, sample size was not calculated for this study, thereby considering this as a pilot study, which forms the limitation of this study. Hence, further studies are recommended with sample size calculation considering this as a pilot study. Only male participants were included, which forms a limitation of the study. The reduction in the plaque and gingival scores is reinforced by the action of brushing as well, apart from the action of intervention. Furthermore, studies on treatment of periodontal diseases using ozone oil can be conducted because it was found to be effective in the treatment of gingivitis without any adverse effects in this study.
| Conclusion|| |
Thus, ozone oil showed a significant reduction in the clinical parameters of PI and GI similar to chlorhexidine gel, thereby signifying its antimicrobial and anti-inflammatory effects on the gingival tissues without any adverse effects, implicating the possession of properties required by a chemotherapeutic agent for the treatment of gingivitis.
Sincere gratitude to Dr. Sonal Kale, Assistant Professor, Department of Public Health Dentistry, Dr. D Y Patil Vidyapeeth Pune, Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune, for proofreading and editing the manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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