NCT07119307

Papilla Preservation Technique in Combination With Tooth Enamel Proteins and Animal Derived Bone Graft in Treating Isolated Bone Defects Between Teeth

Evaluation of Entire Papilla Preservation Technique in Combination With Enamel Matrix Derivative & Bone Mineral Derived Xenograft in Isolated Interdental Intrabony Defects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Rungta College of Dental Sciences and Research · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Periodontal Diseases
• Intrabony Periodontal Defect

Interventions

Type	Name	Description
PROCEDURE	Entire Papilla Preservation Technique	Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD) plus bone mineral derived xenograph (BMDX)
PROCEDURE	Entire Papilla Preservation Surgical Technique (EPPT) alone	Entire Papilla Preservation Surgical Technique (EPPT) alone
PROCEDURE	Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)	Entire Papilla Preservation Surgical Technique (EPPT) alone and combined with enamel matrix derivative (EMD)

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-01-30
• Completion: 2025-03-30
• First posted: 2025-08-13
• Last updated: 2025-09-15

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study