Efficacy of PRF With M-MIST in the Treatment of Intrabony Defects


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Verified May 2017 by Postgraduate Institute of Dental Sciences Rohtak

Sponsor:

Information provided by (Responsible Party):

Postgraduate Institute of Dental Sciences Rohtak

ClinicalTrials.gov Identifier:

NCT03169920

First received: May 24, 2017

Last updated: May 26, 2017

Last verified: May 2017

This study evaluates the efficacy of M-MIST with or without PRF in the treatment of intrabony defects.Taking into consideration of advantages of PRF and M-MIST it was hypothesised that this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabiny defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been previously attempted in periodontal practice.

Periodontitis Procedure: Modified-Minimally Invasive Surgical Technique + PRF
Procedure: Modified-Minimally Invasive Surgical Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Evaluation of the Efficay of Autologous Platelet Rich Fibrin With Modified Minimally Invasive Surgical Technique (M-MIST) in the Treatment of Intrabony Defects: A Randomized Clinical Trial

Primary Outcome Measures:

Estimated Enrollment: 36
Actual Study Start Date: November 30, 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Active Comparator: Test Group

Modified-Minimally Invasive Surgical Technique + PRF

Procedure: Modified-Minimally Invasive Surgical Technique + PRF
Active Comparator: Control Group

Modified-Minimally Invasive Surgical Technique alone.

Procedure: Modified-Minimally Invasive Surgical Technique

Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Systemically healthy chronic periodontitis patients
  • Presence of one tooth with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm associated with an interdental intrabony defect depth of≥3 mm.
  • Only patients with optimal compliance, as assessed during the cause-related phase of therapy, will be selected.
  • Cause related therapy (CRT) including scaling and root planning will be performed and oral hygiene instructions will be given to all the study subjects.

Exclusion Criteria:

  • Systemic illness (chronic inflammatory diseases like diabetes mellitus, arthritis, history of viral infection or pyrexia over the past one month) known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patients having history of receiving antibiotics or periodontal treatment over the past 3 months.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating mothers.
  • Smokers and tobacco chewers.
  • Fractured/perforated roots.
  • Teeth with mobility greater than grade II (Miller 1943) and furcation involvement (class II and class III, Glickman 1953) or with clinical signs of untreated acute infection at surgical site, apical pathology, and severe root irregularities will be excluded.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03169920

Post Graduate Institute of Dental Sciences
Rohtak, Haryana, India, 124001

Postgraduate Institute of Dental Sciences Rohtak

Principal Investigator: Nabeela Ahmed Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA

Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03169920     History of Changes
Other Study ID Numbers: Nabeela perio
Study First Received: May 24, 2017
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 30, 2017