NCT06978036

Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration.

Single-blinded Randomized Non-inferiority Controlled Clinical Trial Comparing Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration of Intra-bony Periodontal Defects

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The standard of care for regeneration of lost periodontal tissue from disease at contained defect sites non-responding to non-surgical periodontal therapy is periodontal regenerative surgery. The classical practice of periodontal regeneration involves an open flap surgical approach with the the application of biologics (Enamel matrix derivatives EMD) and biomaterials after root surface debridement. EMD, derived from porcine, has been well documented for its safety and efficacy and widely used in periodontal regeneration. There is some evidence demonstrating promising treatment outcome of the flapless application of periodontal regenerative biologics after nonsurgical subgingival debridement. Endoscopic-Assisted Subgingival Debridement EASD with a high magnification up to 40X has been shown to be a non-inferior nonsurgical treatment alternative to open flap debridement with shorter operation times and better early wound healing. We hypothesize that EASD could be integrated into flapless periodontal regeneration to improve clinical performance, patient comfort and acceptance to regenerative procedures. Hence, the focus of this study is to investigate whether flapless application of EMD as an adjunct to EASD can achieve non-inferior clinical results compared to classical open-flap periodontal regeneration using Papilla Preservation Surgical Technique PPT in managing residual periodontal intrabony defects 1 year after intervention. Half of the patients will be randomized to recieve EASD and flapless regneration with EMD, while the other half of the patient will receive classical regeneration with PPT and EMD.

Conditions

• Periodontitis
• Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery
• Periodontal Regeneration

Interventions

Type	Name	Description
PROCEDURE	Flapless periodontal regeneration with EMD + EASD	Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
PROCEDURE	Periodontal regeneration with EMD + PPT	Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique

Timeline

• Start date: 2026-01-02
• Primary completion: 2029-02-01
• Completion: 2029-08-01
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: Hong Kong