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Clinical trial

Comparison Of Different Antiplaque Agents On Gingivitis In Patients Undergoing Fixed Orthodontic Treatment: A Double-Blind, Randomized Controlled Trial.

ID
Name
2911
Description
Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis
Trial arms
Trial start
2023-04-01
Estimated PCD
2023-10-31
Trial end
2023-10-31
Status
Completed
Treatment
Chlorhexidine Gluconate
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
Arms:
group A
Other names:
CHX
Metronidazole
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
Arms:
GROUP B
combination gel (chlorhexidine and metronidazole)
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
Arms:
GROUP C
Placebo
For two weeks, all individuals were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, we assigned patients with log sheets to fill daily on whether they used the gel consistently every day twice a day for 2 weeks. Patients were also instructed to return the container of gel on the day of follow-up.
Arms:
GROUP D
Size
80
Primary endpoint
gingival index
12 weeks
bleeding index
12 weeks
orthodontic plaque index
12 weeks
Eligibility criteria
Inclusion Criteria * Patients between the ages of 16 - 35 years with moderate to severe crowding and receiving fixed orthodontic treatment for at least six months were eligible. * Patients with gingival, and ortho plaque indices ≥ 2 and bleeding index ≥ 1 were also included in the inclusion criteria. Exclusion criteria include * systematically unhealthy patients with comorbidities such as blood dyscrasias, rheumatic fever, congenital heart disease, and diabetes mellitus. * Smokers * participants who show no motivation to take care of their teeth, * people with disabilities who are physically dependent in any way. * Patients with allergies to chlorhexidine and metronidazole, * women who are pregnant or lactating. * Patients with clinical attachment loss and calculus.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The trial was a double blinded (patients and investigators). We were helped from a member of our department who is not a part of the study, to transfer the gels from commercial tubes to blank containers. The randomization codes remained unknown until data analysis was completed. Randomization was done by computer-generated software.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2024-03-13

1 organization

4 products

1 indication

Organization
Anam Sattar
Product
Chlorhexidine Gluconate
Indication
Gingivitis
Product
Metronidazole
Product
Combination Gel (Chlorhexidine + Metronidazole)
Product
Placebo