Study Results
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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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2016-04-01
2017-11-29
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars.
3. Systemically healthy patients.
Exclusion Criteria
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.
16 Years
25 Years
ALL
No
Sponsors
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Meenakshi Ammal Dental College and Hospital
OTHER
Responsible Party
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Dr.Jaideep Mahendra
Professor
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.
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.
Other Identifiers
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MADC/IRB-IX/2016/153
Identifier Type: -
Identifier Source: org_study_id
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