PAPILLA PRESERVATION TECHNIQUE IN COMBINATION WITH TOOTH ENAMEL PROTEINS & ANIMAL DERIVED BONE GRAFT IN TREATING ISOLATED BONE DEFECTS BETWEEN TEETH

Not Applicable

Completed

• Conditions: Periodontal Diseases; Intrabony Periodontal Defect

• Registration Number: NCT07119307
• Lead Sponsor: Rungta College of Dental Sciences and Research

Brief Summary

The present three-arm study compared the clinical and tomographic efficacy of the Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derivedxenograph (BMDX), in the treatment of isolated, inter-dental intra-bony defects.

Detailed Description

This randomized controlled clinical and tomographic study included 48 sites with isolated interdental intrabony defects, divided into three groups. Group 1 (control) received EPPT alone, Group 2 received EPPT with EMD, and Group 3 received EPPT with EMD and BMDX (Fix-Oss xenograft). Clinical parameters probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), and papilla height-were recorded at baseline and 12 months. Cone-beam computed tomography (CBCT) was used to evaluate tomographic changes including defect width, CEJ-BD, CEJ-AC, X-ray INFRA and defect angle.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-30
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-30
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

stage II or III periodontitis, according to WWP 2017 classification of periodontal diseases in need of periodontal regenerative treatment for isolated intrabony defects

• Single-rooted teeth/multi-rooted teeth without furcation involvement

Exclusion Criteria

• uncontrolled or poorly controlled diabetes, unstable or life-threatening conditions, or requiring antibiotic prophylaxis, History of use of medications since last 6 months (immunosuppressants and antibiotics), Subjects allergic to medications, Pregnant or lactating women, Smokers/users of other tobacco products, Subjects showing unacceptable oral hygiene maintenance after initial phase I therapy and multiple interconnected vertical defects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
relative attachment level gain	6 months	measuring relative attachment level gain with UNC-15 probe
pocket depth reduction	6 months	measured probing pocket depth changes

Secondary Outcome Measures

Name	Time	Method
Tomographic defect width	6 months	measured defect width in CBCT
the distance between the cemento-enamel junction and the bottom of the defect	6 months	the distance between the cemento-enamel junction and the bottom of the defect

Trial Locations

Locations (1)

Rungta College of Dental Sciences and Research; 🇮🇳 Bhilai, Chhattisgarh, India