Nonsurgical Periodontal Therapy on Banded First Molars

NCT03410602 | Completed Phase 1

• 1 other identifier: MADC/IRB-IX/2016/153
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the effect of nonsurgical periodontal therapy on first molars banded for fixed orthodontic treatment.

Conditions

Periodontitis

Keywords

Nonsurgical periodontal therapy; Orthodontic bands

Outcome Measures

Primary Outcomes (1)

• Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month

  Radiographic evidence of alveolar crestal bone level was measured around each banded first molar

  Baseline to 12th month

Secondary Outcomes (4)

• Change from baseline plaque index at 12th month

  Baseline to 12 month

• Change from baseline gingival index at 12th month

  Baseline to 12th month

• Change from baseline probing pocket depth at 12th month

  Baseline to 12th month

• Change from baseline clinical attachment level at 12th month

  Baseline to 12th month

Study Arms (2)

Supragingival and subgingival scaling

PLACEBO COMPARATOR

Supragingival and subgingival scaling group comprised of 15 orthodontic patients treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling

Subgingival irrigation

ACTIVE COMPARATOR

Subgingival irrigation group comprised of 15 orthodontic patients treated with full-mouth supragingival scaling and subgingival scaling only around all banded first molars followed by irrigation with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent. Parameters such as radiographic evidence of alveolar crestal bone level, gingival index, probing pocket depth and clinical attachment level around the banded first molars and full-mouth plaque index were recorded as a change from baseline to 12th month.

Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling; Drug: Subgingival irrigation

Interventions

Full-mouth supragingival scaling PROCEDURE

Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.

Also known as: Oral prophylaxis

Subgingival irrigation; Supragingival and subgingival scaling

Subgingival scaling PROCEDURE

Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.

Also known as: Deep scaling

Subgingival irrigation; Supragingival and subgingival scaling

Subgingival irrigation DRUG

Test group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.

Also known as: Chemical plaque control

Subgingival irrigation

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both male and female patients within the age group 16 to 25 years.
• Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
• Systemically healthy patients.

You may not qualify if:

• Congenital malformations in the oral cavity.
• Patients who had undergone periodontal therapy within the previous 6 months.
• Patients using removable orthodontic appliances.
• Patients who were administered antibiotics or other systemic or topical antimicrobial agents.
• Smokers.

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Related Publications (2)

• Babay N, Al Jasser N. Subgingival irrigation effects of chlorhexidine or sanguinarine on gingivitis in orthodontic patients. J Clin Pediatr Dent. 1996 Spring;20(3):225-8.

  PMID: 8634210 BACKGROUND

• Morrow D, Wood DP, Speechley M. Clinical effect of subgingival chlorhexidine irrigation on gingivitis in adolescent orthodontic patients. Am J Orthod Dentofacial Orthop. 1992 May;101(5):408-13. doi: 10.1016/0889-5406(92)70113-O.

  PMID: 1590289 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Dental Scaling

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry

Study Officials

• Nashra Kareem, BDS

  Meenakshi Ammal Dental College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 25, 2018
• Study Start: April 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: November 29, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share