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

NCT ID: NCT06978036

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2029-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Flapless EASD + EMD

Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement

Group Type: EXPERIMENTAL

Flapless periodontal regeneration with EMD + EASD

Intervention Type: PROCEDURE

Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement

PPT + EMD

Periodontal regneration with periodontal surgery using Papilla Presevation Technique

Group Type: ACTIVE_COMPARATOR

Periodontal regeneration with EMD + PPT

Intervention Type: PROCEDURE

Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique

Interventions

Flapless periodontal regeneration with EMD + EASD

Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement

Intervention Type: PROCEDURE

Periodontal regeneration with EMD + PPT

Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Stage III - Stage IV Periodontitis patients, 3-4 months after completing steps I & II periodontal therapy.
• At least 1 tooth presented with 1 site with >5mm residual PPD and ≥6mm CAL, with ≥3mm intra-osseous defect presented involving predominantly the interdental space of the tooth and presented on paralleling periapical radiographs and/or CBCT.
• Presence of a periodontally stable tooth with PPD≤3mm immediate adjacent to the intra-bony defect of the investigated tooth
• Good Oral Hygiene, with Full Mouth Plaque Score ≤25% at baseline and with good plaque control at proposed surgical field.

Exclusion Criteria

• Pre-study period

• Any systemic condition which prevents following the study protocol;
• Any systemic condition which may affect healing outcomes of patients, e.g. uncontrolled or poorly controlled diabetes, unstable or life-threatening conditions or those requiring antibiotic prophylaxis;
• Patients under long-term analgesic medication;
• Current smokers;
• Self-reported pregnancy;
• Systemic antimicrobial therapy within 3 months;
• Teeth that concurrently present with a buccal and a lingual intrabony defect component;
• Tooth with hopeless prognosis or questionable prognosis associated with endodontic lesions, or subgingival restorations that preclude clinical measurements, or excessive uncontrolled mobility;
• Any factors which prohibit regular performance of plaque control around surgical sites;
• Inadeduate oral hygiene with full mouth plaque score >25%
• Furcation involved surfaces
• During study period -Non-compliance with study protocol

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Melissa Fok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Melissa R Fok, PhD

Role: CONTACT

melfok@hku.hk

+85228590495

Amy Wong

Role: CONTACT

ammmymei@hku.hk

+85228590485

Other Identifiers

P&ID2025_02

Identifier Type: -

Identifier Source: org_study_id