Nonsurgical Periodontal Therapy on Banded First Molars

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410602
• Other study ID #: MADC/IRB-IX/2016/153
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2018
• Last updated: January 25, 2018
• Start date: April 1, 2016
• Est. completion date: November 29, 2017

Study information

• Verified date: January 2018
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 29, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Full-mouth supragingival scaling
Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.
• Subgingival scaling
Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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