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Clinical Trials/CTRI/2024/09/073429
CTRI/2024/09/073429
Recruiting
Phase 3 4

COMPARISION OF CLINICAL EFFICACY OF MINIMALLY INVASIVE SURGICAL TECHNIQUE (MIST) VERSUS MODIFIED- MINIMALLY INVASIVE SURGICAL TECHNIQUE (M-MIST) IN THE TREATMENT OF PERIODONTAL INFRABONY DEFECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Department of Periodontia and Community dentistry1 site in 1 country80 target enrollmentStarted: September 16, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Recruiting
Sponsor
Department of Periodontia and Community dentistry
Enrollment
80
Locations
1
Primary Endpoint
To evaluate the clinical outcomes in terms of pocket probing depth (PPD) reduction, clinical attachment level (CAL) gain and bone fill (BF) in the treatment of periodontal infrabony defects.

Overview

Brief Summary

Minimally invasive surgery (MIS)/ minimal access surgery (MAS) was introduced with the aim to produce minimal wounds, minimal flap reflection and gentle handling of the soft tissues. Minimally invasive surgical technique (MIST) is based on the elevation of the defect-associated interdental papilla along with minimally extended buccal and lingual flaps. The Modified-MIST is based on elevation of only buccal flap, further enhances the concept of MIST by avoiding the interdental papilla as well as palatal flap dissection and elevation. Minimally invasive surgical technique (MIST) focuses on wound and blood clot stability and primary wound closure for clot protection. This regeneration is possible with reduced patient morbidity, and unaesthetic results are minimized or eliminated. Modified minimally invasive surgical technique (M-MIST) incorporated the concept of space provision for regeneration. In the field of regeneration, there are barrier membranes, grafts, and wound healing modifiers alone or in combinations. Noteworthily, dimensional changes of alveolar bone following tooth loss have remained a prominent challenge for the clinician and a variety of regenerative procedures have since been utilized. One such proposed method has been the use of platelet concentrates, platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (iPRF) which both uses supra-physiological doses of autologous growth factors derived from the patient’s own blood further capable of speeding tissue regeneration. A major problem to overcome applying minimally invasive surgery is the problem of visibility and manipulation of surgical field. High magnification and direct optical illumination provided by a surgical microscope or loupes can be of great help. Also, soft tissue manipulation during instrumentation requires special care. Small instruments like small periosteal elevators, tiny forceps, mini curette are mandatory for gentle manipulation of hard and soft tissues.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • periodontitis (stage III-IV) Systematically healthy patient Contained infrabony defects.

Exclusion Criteria

  • Patients who had received periodontal treatment within the previous three months.
  • Pregnant or lactating Third molars Teeth with grade III mobility.

Outcomes

Primary Outcomes

To evaluate the clinical outcomes in terms of pocket probing depth (PPD) reduction, clinical attachment level (CAL) gain and bone fill (BF) in the treatment of periodontal infrabony defects.

Time Frame: Final clinical and radiographic outcomes will be evaluated at 6 months follow-up.

Secondary Outcomes

  • 1. To evaluate the early healing index of periodontal soft tissue wounds after the surgery.(2. To quantify radiographically, regeneration of interdental bone using CBCT.)

Investigators

Sponsor
Department of Periodontia and Community dentistry
Sponsor Class
Other [Government dental college]
Responsible Party
Principal Investigator
Principal Investigator

Syeda Sumayya Mazhar

Department of Periodontia and community dentistry

Study Sites (1)

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