NCT03169920

Brief Summary

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 intrabony defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been previously attempted in periodontal practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

May 24, 2017

Last Update Submit

May 12, 2019

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

  • PD

    pocket depth

    6 months

  • CAL

    clinical attachment level

    6 months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Modified-Minimally Invasive Surgical Technique + PRF

Procedure: Modified-Minimally Invasive Surgical Technique + PRF

Control Group

ACTIVE COMPARATOR

Modified-Minimally Invasive Surgical Technique alone.

Procedure: Modified-Minimally Invasive Surgical Technique

Interventions

Modified-Minimally Invasive Surgical Technique + PRFPROCEDURE
Test Group
Modified-Minimally Invasive Surgical TechniquePROCEDURE
Control Group

Eligibility Criteria

Age28 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Related Publications (1)

  • Ahmad N, Tewari S, Narula SC, Sharma RK, Tanwar N. Platelet-rich fibrin along with a modified minimally invasive surgical technique for the treatment of intrabony defects: a randomized clinical trial. J Periodontal Implant Sci. 2019 Oct 9;49(6):355-365. doi: 10.5051/jpis.2019.49.6.355. eCollection 2019 Dec.

    PMID: 31886028DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Nabeela Ahmed

    Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA

    PRINCIPAL INVESTIGATOR

  • SHIKHA TEWARI

    Post Graduate Institute of Dental Sciences, Rohtak. HARYANA .INDIA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

November 30, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)