Nonsurgical Periodontal Therapy on Banded First Molars

NCT ID: NCT03410602

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-11-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Full-mouth supragingival scaling

Intervention Type PROCEDURE

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

Subgingival scaling

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Full-mouth supragingival scaling

Intervention Type PROCEDURE

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

Subgingival scaling

Intervention Type PROCEDURE

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

Subgingival irrigation

Intervention Type 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.

Interventions

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Full-mouth supragingival scaling

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

Intervention Type PROCEDURE

Subgingival scaling

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

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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Oral prophylaxis Deep scaling Chemical plaque control

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr.Jaideep Mahendra

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nashra Kareem, BDS

Role: PRINCIPAL_INVESTIGATOR

Meenakshi Ammal Dental College and Hospital

References

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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.

Reference Type BACKGROUND
PMID: 8634210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1590289 (View on PubMed)

Other Identifiers

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MADC/IRB-IX/2016/153

Identifier Type: -

Identifier Source: org_study_id

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