A clinical and radiographic trial to study the treatment outcomes for bony defects using autograft VS combination of demineralized bone matrix and autograft.

Phase 4

Recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2023/11/059834

Brief Summary

Aim of the study is to compare the treatment outcomes forintrabony vertical defects using autogenous bone graft alone and combination ofdemineralized bone matrix and autogenous bone graft. All participants will beexplained about the need and design of the study. Informed consent will beobtained from the patients. Through clinical case history will berecorded. Each patient will undergo ultrasonic scaling (EMS) by a singleoperator. All clinical parameters (GI, PI, PPD, CAL, BOP) will be recorded usingUNC15 periodontal probe (Hu Friedy )  at baseline, 3 months and 6 monthsinterval. It is a single blind study in which the patient will be randomlyassigned to either autogenous bone graft group (control) or combination ofdemineralized bone matrix and autogenous bone graft group (test) using manuallottery method. After allotment of the groups following surgical method will beperformed. . Intraoral antisepsis will be performed with 10ml of 0.2%chlorhexidine digluconate rinse and by a povidine iodine solution extra oralantisepsis will be carried out. The site scheduled for surgery will beanesthetized by appropriate local anesthesia.  After administration of local anesthesia,incisions  will be made intracrevicularly  through the bottom of thepocket on both facial and the lingual/palatal as well as interdental  area. Incision will be performed from distal to mesial aspect ofthe area planned for the surgery. Mucoperiosteal flaps will be elevated beyond the mucogingivaljunction in order to achieve primary closure in all cases irrespective ofgroups. The marginal bone and diseased root surfaces will be exposed. Care will be taken to preserve as much interproximal soft tissue aspossible. Meticulous defect debridement and root planning will be carried outusing hand instruments and area-specific curettes in order to remove calculus,necrotic cementum and granulation tissues. No osseous recontouring will be performed, similarprocedure will be performed for both control site and the test site. Control site will be treated with autogenous bone graft alone and testsite will be treated with autogenous bone graft and demineralized bone matrix. The piezo electric device will be used for bone removalfor autogenous bone grafting. It will placed directly into the recipient site. Autogenous bone graft of the required size will be procured byextending the mucoperiosteal flap in the adjacent tooth area to cover theosseous defect in the control group.  Combination of ABG + DMM will be used to cover theosseous defect in the test group. Mucoperiosteal flaps will be repositioned and securedin place using non-absorbable black silk suture. The interrupted sutures will be placed. The surgical area will be protected and covered withperiodontal dressing. The following post operative care will be given to thepatients Sutures will be removed after 7-10 days postoperatively.  Antibiotics & Analgesics will be prescribed. Each patient will be instructed for proper oral hygiene measure ateach appointment. Patients will be instructed to avoid using toothbrush at thesurgical site. Teeth cleaning will be initiated with gentle brushing using softbrush after suture removal. All clinical parameters will be re-evaluated 3 months and 6months after surgery by second blinded operator. Radiographic parameters willbe re-evaluated 6 months after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.PRESENCE OF PERIODONTITIS WITH VERTICAL INTRABONY DEFECT HAVING PROBING POCKET DEPTH PPD MORE THAN OR EQUAL TO 5 MM, RADIOGRAPHIC DEFECT DEPTH MORE THAN OR EQUALTO 3MM AFTER PHASE I THERAPY.
• 2.ABSENCE OF ANY ANATOMICAL LIMITATIONS.
• 3.PATIENT WILLING TO UNDERGO SURGERY AND READY TO GIVE WRITTEN CONSENT.

Exclusion Criteria

• 1. Patients with systemic diseases, smokers and pregnant and lactating women.
• 2. Individuals with unacceptable oral hygiene.
• 3. Patients contraindicated for periodontal surgery.
• 4. Patients undergone periodontal therapy for past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COMPARE REDUCTION IN PROBING DEPTH FOR INTRABONY VERTICAL DEFECTS	Baseline to 6 months

Trial Locations

Locations (1)

SMBT Dental college and hospital; 🇮🇳 Ahmadnagar, MAHARASHTRA, India

SMBT Dental college and hospital

🇮🇳Ahmadnagar, MAHARASHTRA, India

Dr Sakshi Kanherkar

Principal investigator

9870531997

sakshik0305@gmail.com