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

NCT06978036 | Not Yet Recruiting

• 1 other identifier: P&ID2025_02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

Periodontitis; Intrabondy defects; Perioscope; Perioscopy; endoscope-assisted; regeneration; papilla preservation; enamel matrix derivative

Outcome Measures

Primary Outcomes (1)

• ΔCAL - 12 months

  Change of Clinical Attachment Level measured in millimetres

  12 months

Secondary Outcomes (14)

• ΔCAL - 6 months

  6 months

• ΔCAL - 9 months

  9 months

• FMPS

  3, 6, 9, 12 months

• FMBOP

  3, 6, 9, 12 months

• ΔREC

  3, 6, 9, 12 months

Study Arms (2)

Flapless EASD + EMD

EXPERIMENTAL

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

Procedure: Flapless periodontal regeneration with EMD + EASD

PPT + EMD

ACTIVE COMPARATOR

Periodontal regneration with periodontal surgery using Papilla Presevation Technique

Procedure: Periodontal regeneration with EMD + PPT

Interventions

Flapless periodontal regeneration with EMD + EASD PROCEDURE

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

Flapless EASD + EMD

Periodontal regeneration with EMD + PPT PROCEDURE

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

PPT + EMD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Periodontitis

Interventions

emerin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Melissa R Fok, PhD

CONTACT

+85228590495; melfok@hku.hk

Amy Wong

CONTACT

+85228590485; ammmymei@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blinded randomized non-inferiority controlled clinical trial

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)