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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis; Periodontal Regeneration; Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery
• Intervention / Treatment: Procedure: Flapless periodontal regeneration with EMD + EASD; Procedure: Periodontal regeneration with EMD + PPT

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa R Fok, PhD; Phone Number: +85228590495; Email: melfok@hku.hk
• Study Contact Backup: Name: Amy Wong; Phone Number: +85228590485; Email: ammmymei@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flapless EASD + EMD; Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement	Procedure: Flapless periodontal regeneration with EMD + EASD; Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
Active Comparator: PPT + EMD; Periodontal regneration with periodontal surgery using Papilla Presevation Technique	Procedure: Periodontal regeneration with EMD + PPT; Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔCAL - 12 months	Change of Clinical Attachment Level measured in millimetres	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔCAL - 6 months	Change of Clinical Attachment Level, measured in milimetres	6 months
ΔCAL - 9 months	Change of Clinical Attachment Level, measured in milimetres	9 months
FMPS	Modified O'Leary Full Mouth Plaque Score, measured in percentage	3, 6, 9, 12 months
FMBOP	Full Mouth Bleeding On Probing (excluding teeth under investigation), measured in percentage	3, 6, 9, 12 months
ΔREC	Change in Recession , measured in milimetres	3, 6, 9, 12 months
ΔPPD	Change in Periodontal Pocket Depth, measrued in millimetres	6, 9, 12 months
Mob	Tooth Mobility Index (Miller 1938), the higher the number the greater the mobility	3, 6, 9, 12 months
EWHI	Early Wound Healing Index (Wachtel et al., 2003), a lower score signifies a better healing	3, 6, 9, 12 months
ΔINFRA	Change of depth of the intrabony defect , measured on radiographs in millimetres.	3, 6, 9, 12 months
TIME	Time for the surgery , measured in minutes	Measured throughout procedure
% of sites achieving therapeutic endpoints	% of sites achieving therapeutic endpoints (i.e. no PPD > 4mm with bleeding and no deep residual pocket PPD >5mm)	6, 9, 12 months
Patient-reported outcome measurements	Subjects will be assessed with a questionnaire on condition-specific Health-related quality-of-life instrument and perceptions of oral health-related quality of life will be assessed using validated translations of the OHIP-14 questionnaire into the native language of all participants. A lower value indicates a more favourable patient-reported outcome.	Baseline, 3, 6, 9, 12 months
Intra-operative Discomfort	100mm Visual Analog Scale is used to measure the intra-operative pain and discomfort during the test/control therapy.	14 days
Daily intake of analgesia	Daily intake of analgesia will be recorded on the first 14 days after the operation.	14 days

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: May 10, 2025
• First Submitted That Met QC Criteria: May 10, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Periodontitis; regeneration; enamel matrix derivative; papilla preservation; Intrabondy defects; Perioscope; Perioscopy; endoscope-assisted
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: P&ID2025_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is concern that individual participant data sharing may violate data ownership policy of the institute. Information sheet and consent form approved by local IRB did not explicitly permit data sharing beyond the scope of the current study. As such, sharing IPD could potentially infringe upon the rights and expectations of our participants, which we are committed to safeguarding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No