Comparing Treatments for Vertical Bone Defects: Autografts, Demineralised bone matrix, and Demineralised bone matrix with I-PRF.

Phase 4

Not yet recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2025/04/085890
• Lead Sponsor: Dr Pooja Singh

Brief Summary

This study aims to compare the treatment outcomes for intrabony vertical defects using three different regenerative techniques: intraoral osseous autograft, demineralized bone matrix (DBM) alone, and a combination of DBM and injectable platelet-rich fibrin (i-PRF). It seeks to evaluate both clinical and radiographic outcomes, including probing depth, clinical attachment level, gingival recession, bone fill, and defect morphology. A randomized controlled trial design will be employed, with patients having vertical intrabony defects undergoing standardized surgical procedures. Follow-up evaluations will occur at 3, 6, and 12 months post-treatment to assess the effectiveness of each technique.

The clinical evaluation will focus on parameters such as probing depth, clinical attachment level, and postoperative pain, while radiographic evaluation will assess the degree of bone regeneration and changes in defect morphology. The study hypothesizes that intraoral osseous autograft, being a gold standard, will show superior results in bone regeneration. DBM alone is expected to provide moderate regeneration, while the combination of DBM and i-PRF may offer enhanced healing due to the growth factors in the platelet-rich fibrin. The findings will provide valuable insights into the effectiveness of these treatment options and help optimize regenerative protocols for managing periodontal defects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-29
• Study Start: 2025-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 1.Presence of periodontitis with vertical intrabony defect having probing pocket depth PPD greater than or equal to 5 mm, radiographic defect depth greater than or equal to 3mm after phase I therapy (scaling and root planning).
• 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 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
i.Plaque index	Baseline three months six months
iii.Probing pocket depth (PPD) in mm.	Baseline three months six months
ii. Gingival index	Baseline three months six months
iv. Relative clinical attachment level (RCAL) in mm is measured from the fixed marked point at apical level of customized acrylic stents to the base of pocket with grooves to ensure a reproducible placement of a periodontal (UNC 15) probe.	Baseline three months six months
v. Bleeding on probing (Ainamo and Bay 1976)	Baseline three months six months
vi.Radiographic measurements. Radiographic measurements will be carried out on intra oral periapical radiographs by paralleling technique with grid (having 1 mm compartments)	Baseline three months six months

Trial Locations

Locations (1)

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

SMBT Dental college and hospital

🇮🇳Ahmadnagar, MAHARASHTRA, India

Dr Pooja Singh

Principal investigator

9004843680

poojavsingh1803@gmail.com