Nonsurgical Periodontal Therapy on Banded First Molars

• ClinicalTrials.gov Identifier: NCT03410602
• Recruitment Status: Completed
• First Posted: January 25, 2018
• Last Update Posted: January 26, 2018
• Sponsor: Meenakshi Ammal Dental College and Hospital
• Information provided by (Responsible Party): Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Periodontitis	Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling; Drug: Subgingival irrigation	Phase 1

Detailed Description:

A total of 30 patients who were about to undergo fixed orthodontic therapy were selected and divided into two groups.

Group A comprised of 15 patients who were treated with routine full-mouth supragingival scaling and subgingival scaling only around all banded first molars.

Group B comprised of 15 patients who were 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. Treatment for both the groups was performed at 3rd month, 6th month and 9th month.

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. The differences between the values were assessed and sent for statistical analysis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: August 30, 2017
• Actual Study Completion Date: November 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Supragingival and subgingival scaling; 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; Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.; Other Name: Oral prophylaxis; Procedure: Subgingival scaling; Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.; Other Name: Deep scaling
Active Comparator: Subgingival irrigation; 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; Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.; Other Name: Oral prophylaxis; Procedure: Subgingival scaling; Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.; Other Name: Deep scaling; Drug: Subgingival irrigation; 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.; Other Name: Chemical plaque control

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month [ Time Frame: Baseline to 12th month ]
   Radiographic evidence of alveolar crestal bone level was measured around each banded first molar

Secondary Outcome Measures :

1. Change from baseline plaque index at 12th month [ Time Frame: Baseline to 12 month ]
   Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).
2. Change from baseline gingival index at 12th month [ Time Frame: Baseline to 12th month ]
   The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).
3. Change from baseline probing pocket depth at 12th month [ Time Frame: Baseline to 12th month ]
   The probing pocket depth was measured clinically using Williams periodontal probe at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, distolingual and lingual) of each banded first molar.
4. Change from baseline clinical attachment level at 12th month [ Time Frame: Baseline to 12th month ]
   Clinical attachment level (CAL) was measured as the distance between a fixed point on the crown such as cementoenamel junction to the base of the pocket.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Sponsors and Collaborators

Meenakshi Ammal Dental College and Hospital

Investigators

• Principal Investigator: Nashra Kareem, BDS; Meenakshi Ammal Dental College and Hospital

More Information

Publications:

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.

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.

• Responsible Party: Dr.Jaideep Mahendra, Professor, Meenakshi Ammal Dental College and Hospital
• ClinicalTrials.gov Identifier: NCT03410602
• Other Study ID Numbers: MADC/IRB-IX/2016/153
• First Posted: January 25, 2018
• Last Update Posted: January 26, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:

Nonsurgical periodontal therapy; Orthodontic bands

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases