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Clinical Trials/CTRI/2017/11/010348
CTRI/2017/11/010348CompletedNot Applicable

Efficacy of Laser Assisted New Attachment Procedure(LANAP) as an adjunct to Scaling and Root Planning (SRP) in Controlled Type 2 Diabetes Mellitus Patients with Chronic Periodontitis: A Clinical and Microbiological study

JSS University1 site in 1 country40 target enrollmentStarted: April 29, 2016Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
improvement in clinical parameters such as plaque index, gingival index, probing depth, clinical attachment level and improvement in Glycated Haemoglobin level HbA1c

Study Overview

Brief Summary

SUMMARY

Periodontal therapy for the treatment ofperiodontitis involves the elimination of bacterial plaque. Considering thevarious advantages of laser irradiation, its use in combination with conventionalmechanical treatment has the potential to improve the periodontal condition than mechanical therapy alone. Also,considering the evidence of bacterial invasion into the soft tissue ofperiodontal pockets, not only debridement of the root surface but also removalof the epithelium lining and granulation tissue of the gingival wall withinperiodontal pockets could be an important factor in the treatment of moderateto deep pockets in order to promote attachment of gingival connective tissue tothe root surface. The present clinical study was designed to compare andevaluate the bactericidal effects of Laser Assisted New Attachment Procedure (LANAP) as an adjunct to scaling and rootplaning on the various clinical and microbiological parameters and theimprovement in glycemic control (HbA1c) .

The primary aim of the present study was todetermine the efficacy of the LANAP as an adjunct to scaling and root planingin the treatment of periodontal pockets in Type 2 Diabetes Mellitus (DM2) patients with chronicperiodontitis. From  the  observations of  the  present study  it  can be  suggested  that the therapeutic effectiveness of LANAP as an adjunct to scaling and rootplaning is having an additional benefit over scaling and root planing alone interms of clinical and microbiological parameters. However no statisticallysignificant difference between two groups in terms of glycemic control wasdocumented in this study. Added advantages of Diode laser are: better patientcompliance, enhanced/ improved tissue response, greater ability to sterilizethe periodontal pocket and true bactericidal potential. Thus Laser can be auseful tool in the treatment of periodontitis patients with systemic diseases.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Investigator Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Patients with confirmed diagnosis of Type 2 diabetes mellitus.
  • 2 Generalized moderate to severe chronic periodontitis and ≥20 remaining teeth.
  • 3 Each quadrant containing at least 3 teeth with periodontal pocket depth of 4-7mm and clinical attachment level of 2mm or greater.
  • 4 Consenting patients who are co-operative and able to come for regular follow up.

Exclusion Criteria

  • 1 Pregnant /lactating women.
  • 2 Patients who are on antibiotic therapy in the previous six months.
  • 3 Patients who have undertaken any periodontal therapy in past 6 months.
  • 5 Alcoholism.

Outcomes

Primary Outcomes

improvement in clinical parameters such as plaque index, gingival index, probing depth, clinical attachment level and improvement in Glycated Haemoglobin level HbA1c

Time Frame: from baseline to 3 months

Secondary Outcomes

  • reduction in periodontal microbiology of anaerobic bacteria Aggregatibacter actinimycetemcomitans and porphyromonas gingivalis(from baseline to 3 months)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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