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Clinical Trials/NCT04100798
NCT04100798
Completed
Not Applicable

Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Cairo University1 site in 1 country16 target enrollmentFebruary 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrabony Periodontal Defect
Sponsor
Cairo University
Enrollment
16
Locations
1
Primary Endpoint
Clinical attachment Level gain (CAL gain)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. This would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (Tonetti, Greenwell, & Kornman, 2018).

The main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. Evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. The purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, & Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. Where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (Pierpaolo Cortellini & Tonetti, 2015) This randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous defects in stage III periodontitis patients.

Registry
clinicaltrials.gov
Start Date
February 8, 2020
End Date
November 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mostafa Ebrahim Mohamed Mokhtar

PHD Candidate

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients age between 20 and 60 years old.
  • Stage III periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area.
  • Vital teeth
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Pregnant females
  • Drug abusers

Outcomes

Primary Outcomes

Clinical attachment Level gain (CAL gain)

Time Frame: 12 months

CAL gain will be determined by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC 15 periodontal probe.

Secondary Outcomes

  • Post-surgical patient satisfaction(12 months)
  • Pocket depth (PD)(12 months)
  • Gingival recession (GR)(12 months)
  • Radiographic defect fil(12 months)
  • Gingival bleeding score(12 months)

Study Sites (1)

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