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NCT Number: NCT06978036

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flapless periodontal regeneration with EMD + EASD

Procedure

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

Periodontal regeneration with EMD + PPT

Procedure

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

Primary outcomes

  1. ΔCAL - 12 months

    Time frame: 12 months

    Change of Clinical Attachment Level measured in millimetres

Secondary outcomes

  1. ΔCAL - 6 months

    Time frame: 6 months

    Change of Clinical Attachment Level, measured in milimetres

  2. ΔCAL - 9 months

    Time frame: 9 months

    Change of Clinical Attachment Level, measured in milimetres

  3. FMPS

    Time frame: 3, 6, 9, 12 months

    Modified O'Leary Full Mouth Plaque Score, measured in percentage

  4. FMBOP

    Time frame: 3, 6, 9, 12 months

    Full Mouth Bleeding On Probing (excluding teeth under investigation), measured in percentage

  5. ΔREC

    Time frame: 3, 6, 9, 12 months

    Change in Recession , measured in milimetres

  6. ΔPPD

    Time frame: 6, 9, 12 months

    Change in Periodontal Pocket Depth, measrued in millimetres

  7. Mob

    Time frame: 3, 6, 9, 12 months

    Tooth Mobility Index (Miller 1938), the higher the number the greater the mobility

  8. EWHI

    Time frame: 3, 6, 9, 12 months

    Early Wound Healing Index (Wachtel et al., 2003), a lower score signifies a better healing

  9. ΔINFRA

    Time frame: 3, 6, 9, 12 months

    Change of depth of the intrabony defect , measured on radiographs in millimetres.

  10. TIME

    Time frame: Measured throughout procedure

    Time for the surgery , measured in minutes

  11. % of sites achieving therapeutic endpoints

    Time frame: 6, 9, 12 months

    % of sites achieving therapeutic endpoints (i.e. no PPD > 4mm with bleeding and no deep residual pocket PPD >5mm)

  12. Patient-reported outcome measurements

    Time frame: Baseline, 3, 6, 9, 12 months

    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.

  13. Intra-operative Discomfort

    Time frame: 14 days

    100mm Visual Analog Scale is used to measure the intra-operative pain and discomfort during the test/control therapy.

  14. Daily intake of analgesia

    Time frame: 14 days

    Daily intake of analgesia will be recorded on the first 14 days after the operation.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Wong

CONTACT

[email protected]

+85228590485

Melissa R Fok, PhD

CONTACT

[email protected]

+85228590495

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Acronym: EAFAR

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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