Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients

NCT06305546 | Completed DMC

• 1 other identifier: 2911
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingivitis

Keywords

gingivitis,; fixed orthodontic treatment,; anti plaque gels

Outcome Measures

Primary Outcomes (3)

• gingival index

  Gingival index Score 0: no inflammation Score 1: Mild inflammation of gingiva. No bleeding on probing. Score2: Moderate inflammation, Red, edematous and shiny gingiva, bleeding on probing. Score 3: Severe inflammation, Red, edematous and ulcerated gingiva. There is spontaneous bleeding

  12 weeks

• bleeding index

  Bleeding Index Score 0: absence of bleeding after 30 seconds Score 1: presence of bleeding after 30 seconds Score 2: immediate bleeding

  12 weeks

• orthodontic plaque index

  Orthodontic Plaque Index 0: No plaque deposits on the tooth surfaces surrounding the bracket base 1. Plaque deposits on one tooth surface at the bracket base 2. Plaque deposits on two tooth surfaces at the bracket base 3. Plaque deposits on three tooth surfaces at the bracket base 4. Plaque deposits on four tooth surfaces at the bracket base

  12 weeks

Study Arms (4)

group A

EXPERIMENTAL

Drug: Chlorhexidine Gluconate

GROUP B

EXPERIMENTAL

Drug: Metronidazole

GROUP C

EXPERIMENTAL

Drug: combination gel (chlorhexidine and metronidazole)

GROUP D

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Chlorhexidine Gluconate DRUG

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.

Also known as: CHX

group A

Metronidazole DRUG

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.

GROUP B

combination gel (chlorhexidine and metronidazole) DRUG

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.

GROUP C

Placebo DRUG

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.

GROUP D

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anam Sattar: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Gingivitis

Interventions

chlorhexidine gluconate; Metronidazole; Chlorhexidine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Registrar, Department of Orthodontics, Principal Investigator.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: March 12, 2024
• Study Start: April 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

PA (1)