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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery; Periodontitis; Periodontal Regeneration

Treatments: Procedure: Periodontal regeneration with EMD + PPT; Procedure: Flapless periodontal regeneration with EMD + EASD

Study type: Interventional

Funder types: Other

Identifiers

NCT06978036

P&ID2025_02

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

56 participants in 2 patient groups

Flapless EASD + EMD

Experimental group

Description:

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

Treatment:

Procedure: Flapless periodontal regeneration with EMD + EASD

PPT + EMD

Active Comparator group

Description:

Periodontal regneration with periodontal surgery using Papilla Presevation Technique

Treatment:

Procedure: Periodontal regeneration with EMD + PPT