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

NCT04100798 | Completed

• 1 other identifier: PER 3-3-2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• Clinical attachment Level gain (CAL gain)

  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.

  12 months

Secondary Outcomes (5)

• Pocket depth (PD)

  12 months

• Gingival recession (GR)

  12 months

• Radiographic defect fil

  12 months

• Gingival bleeding score

  12 months

• Post-surgical patient satisfaction

  12 months

Study Arms (2)

Entire Papilla Preservation (EPP) technique

EXPERIMENTAL

A minimally invasive surgical technique that involves using a vertical incision away from the defect area in order to preserve the integrity of the related interdental papilla and elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap

Procedure: Entire Papilla Preservation technique

Modified Minimally invasive Surgical Technique (M-MIST)

ACTIVE COMPARATOR

A minimally invasive surgical technique that involves using a horizontal interdental incision that extends to the buccal aspect of the two teeth adjacent to the intraosseous defect then elevating a full thickness flap then using microsurgical instruments to properly debride the intraosseous defect before closing the flap

Procedure: Modified Minimally invasive Surgical Technique

Interventions

Entire Papilla Preservation technique PROCEDURE

A minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it

Also known as: EPP

Entire Papilla Preservation (EPP) technique

Modified Minimally invasive Surgical Technique PROCEDURE

a minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it.

Also known as: M-MIST

Modified Minimally invasive Surgical Technique (M-MIST)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, 00202, Egypt

Location

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: PRINCIPAL INVESTIGATOR
• PI Title: PHD Candidate

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: September 24, 2019
• Study Start: February 8, 2020
• Primary Completion: September 2, 2021
• Study Completion: November 15, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

EG (1)