Nonsurgical Periodontal Therapy on Banded First Molars

Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Full-mouth supragingival scaling; Procedure: Subgingival scaling; Drug: Subgingival irrigation

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Oral prophylaxis; Procedure: Subgingival scaling; Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.; Other Names: 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 Names: Oral prophylaxis; Procedure: Subgingival scaling; Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.; Other Names: 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 Names: Chemical plaque control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline plaque index at 12th month	Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).	Baseline to 12 month
Change from baseline gingival index at 12th month	The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).	Baseline to 12th month
Change from baseline probing pocket depth at 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.	Baseline to 12th month
Change from baseline clinical attachment level at 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.	Baseline to 12th month

Collaborators and Investigators

• Sponsor: Meenakshi Ammal Dental College and Hospital
• Investigators: Principal Investigator: Nashra Kareem, BDS, Meenakshi Ammal Dental college and hospital

Publications and helpful links

General 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. doi: 10.1016/0889-5406(92)70113-O.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): August 30, 2017
• Study Completion (ACTUAL): November 29, 2017

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (ACTUAL): January 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Nonsurgical periodontal therapy; Orthodontic bands
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: MADC/IRB-IX/2016/153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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