Clinical trial NCT03410602: Nonsurgical Periodontal Therapy on Banded First Molars
Official title: Effect on Nonsurgical Periodontal Therapy on First Molars Banded for Fixed Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontitis
Keywords: Nonsurgical periodontal therapy
Orthodontic bands
Lead sponsor: Meenakshi Ammal Dental College and Hospital
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month
timeFrame: Baseline to 12th month
Secondary outcomes:
measure: Change from baseline plaque index at 12th month
timeFrame: Baseline to 12 month
measure: Change from baseline gingival index at 12th month
timeFrame: Baseline to 12th month
measure: Change from baseline probing pocket depth at 12th month
timeFrame: Baseline to 12th month
measure: Change from baseline clinical attachment level at 12th month
timeFrame: Baseline to 12th month
Other outcomes:
Locations:
Study officials:
affiliation: Meenakshi Ammal Dental College and Hospital
name: Nashra Kareem, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/0889-5406(92)70113-O.