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Completed

NCT Number: NCT03410602

Nonsurgical Periodontal Therapy on Banded First Molars

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full-mouth supragingival scaling

Procedure

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

Other names: Oral prophylaxis

Subgingival scaling

Procedure

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

Other names: Deep scaling

Subgingival irrigation

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.

Other names: Chemical plaque control

Primary outcomes

  1. Change from Baseline radiographic evidence of alveolar crestal bone level at 12th month

    Time frame: Baseline to 12th month

    Radiographic evidence of alveolar crestal bone level was measured around each banded first molar

Secondary outcomes

  1. Change from baseline plaque index at 12th month

    Time frame: Baseline to 12 month

    Full-mouth plaque index measurements were carried out at four sites around each tooth (mesiobuccal, buccal, distobuccal and lingual).

  2. Change from baseline gingival index at 12th month

    Time frame: Baseline to 12th month

    The measurements were carried out around all the banded first molars at four sites (mesiobuccal, buccal, distobuccal and lingual).

  3. Change from baseline probing pocket depth at 12th month

    Time frame: Baseline to 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.

  4. Change from baseline clinical attachment level at 12th month

    Time frame: Baseline to 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.

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2018
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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