Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Chlorhexidine Gluconate; Drug: Metronidazole; Drug: combination gel (chlorhexidine and metronidazole); Drug: Placebo

Detailed Description

Metal brackets were used on the teeth such as incisors, canines, and premolars as well as bands on the 1st molars to treat all patients with the same kind of orthodontic appliances. Metal Brackets were bonded by the principal investigator with the direct bonding technique by using light cure adhesives. General oral hygiene instructions were given by the clinician to each participant in the study.

Participants were divided into four groups through computer-generated software. Group A participants used 1% metronidazole gel, Group B participants used 0.25% chlorhexidine gel. Group C participants used a combination gel (1% Metronidazole and 0.25% Chlorhexidine). Group D participants used a placebo gel. All participants were instructed to follow oral hygiene measures such as brushing twice a day with a soft brush with fluoridated toothpaste, and use of floss or interdental brushes. For two weeks, all individuals from groups A, B, C, and D were instructed to use pea-sized gel on their gingiva two times a day. To ensure patient compliance, the investigators 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.

OUTCOMES:

The primary outcome included the measurement of indices during study time from baseline (T0) to 2weeks (T1), 4 weeks (T2), 8 weeks (T3) and 12 weeks(T4) . The investigators have evaluated Gingival Index and Bleeding Index by probing and assessing the gingiva and Orthodontic Plaque index by plaque disclosing tablets, and examined six standard sites on incisors, canine, and premolars as described by Gettinger et al. Banded first molars were not included because banding itself can compromise periodontal health. The study sites were assessed by using CPITN probe. Six proximal line angles were investigated for gingivitis on the selected teeth: Right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distopalatal line angle; right mandibular central incisor, distolingual line angle; left mandibular canine, distobuccal line angle; left mandibular second premolar, mesiobuccal line angle.

If any of the study teeth were missing, then the corresponding tooth on the opposite side was evaluated.

Patients were only included in the trial if they have Gingival index, Orthodontic plaque index scores ≥2 and Bleeding index ≥ 1 on any three or more than three of the six teeth that were examined in the study. The total combined GI and BI indexes were computed by averaging the measured values at T0, T1, T2, T3 and T4 . For OPI, the score was calculated by counting the number of teeth with plaque accumulation at each time interval.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A	Drug: 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.; Other Names: CHX
Experimental: GROUP B	Drug: 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.
Experimental: GROUP C	Drug: 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.
Placebo Comparator: GROUP D	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Plaque deposits on one tooth surface at the bracket base; Plaque deposits on two tooth surfaces at the bracket base; Plaque deposits on three tooth surfaces at the bracket base; Plaque deposits on four tooth surfaces at the bracket base	12 weeks

Collaborators and Investigators

• Sponsor: Anam Sattar

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: gingivitis,; fixed orthodontic treatment,; anti plaque gels
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Disinfectants; Metronidazole; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No