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Nonsurgical Periodontal Therapy on Banded First Molars

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Full-mouth supragingival scaling
Subgingival scaling
Subgingival irrigation
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Nonsurgical periodontal therapy, Orthodontic bands

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Supragingival and subgingival scaling

    Subgingival irrigation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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).
    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).
    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.
    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.

    Full Information

    First Posted
    January 4, 2018
    Last Updated
    January 25, 2018
    Sponsor
    Meenakshi Ammal Dental College and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03410602
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    August 30, 2017 (Actual)
    Study Completion Date
    November 29, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meenakshi Ammal Dental College and Hospital

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    Nonsurgical periodontal therapy, Orthodontic bands

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supragingival and subgingival scaling
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Subgingival irrigation
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Full-mouth supragingival scaling
    Other Intervention Name(s)
    Oral prophylaxis
    Intervention Description
    Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.
    Intervention Type
    Procedure
    Intervention Name(s)
    Subgingival scaling
    Other Intervention Name(s)
    Deep scaling
    Intervention Description
    Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.
    Intervention Type
    Drug
    Intervention Name(s)
    Subgingival irrigation
    Other Intervention Name(s)
    Chemical plaque control
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month
    Description
    Radiographic evidence of alveolar crestal bone level was measured around each banded first molar
    Time Frame
    Baseline to 12th month
    Secondary Outcome Measure Information:
    Title
    Change from baseline plaque index at 12th month
    Description
    Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).
    Time Frame
    Baseline to 12 month
    Title
    Change from baseline gingival index at 12th month
    Description
    The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).
    Time Frame
    Baseline to 12th month
    Title
    Change from baseline probing pocket depth at 12th month
    Description
    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.
    Time Frame
    Baseline to 12th month
    Title
    Change from baseline clinical attachment level at 12th month
    Description
    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.
    Time Frame
    Baseline to 12th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both male and female patients within the age group 16 to 25 years. Patients diagnosed with malocclusion undergoing fixed orthodontic treatment having banded first molars. Systemically healthy patients. Exclusion Criteria: Congenital malformations in the oral cavity. Patients who had undergone periodontal therapy within the previous 6 months. Patients using removable orthodontic appliances. Patients who were administered antibiotics or other systemic or topical antimicrobial agents. Smokers.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nashra Kareem, BDS
    Organizational Affiliation
    Meenakshi Ammal Dental College and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8634210
    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.
    Results Reference
    background
    PubMed Identifier
    1590289
    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.
    Results Reference
    background

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    Nonsurgical Periodontal Therapy on Banded First Molars

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