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PeriodontitisEAFARNCT06978036

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

A study testing Flapless periodontal regeneration with EMD + EASD and Periodontal regeneration with EMD + PPT in people with Periodontitis and Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery, run by The University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Flapless periodontal regeneration with EMD + EASD and Periodontal regeneration with EMD + PPT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteHong Kong
Study dates
2 Jan 2026to Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa R Fok, PhD contact

+85228590495

melfok@hku.hk

Amy Wong contact

+85228590485

ammmymei@hku.hk

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official 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

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.

Being tested
Flapless periodontal regeneration with EMD + EASD, Periodontal regeneration with EMD + PPT
Keywords
Periodontitis, Intrabondy defects, Perioscope, Perioscopy, endoscope-assisted, regeneration, papilla preservation, enamel matrix derivative
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flapless periodontal regeneration with EMD + EASDProcedure or surgery

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

  • Periodontal regeneration with EMD + PPTProcedure or surgery

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

Study groups in NCT06978036
Study groupRoleWhat they receive
Flapless EASD + EMDExperimentalPeriodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
Receives: Procedure: Flapless periodontal regeneration with EMD + EASD
PPT + EMDActive comparatorPeriodontal regneration with periodontal surgery using Papilla Presevation Technique
Receives: Procedure: Periodontal regeneration with EMD + PPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ΔCAL - 12 months

    Change of Clinical Attachment Level measured in millimetres

    Measured: 12 months

Secondary outcomes (14)

  1. ΔCAL - 6 months

    Change of Clinical Attachment Level, measured in milimetres

    Measured: 6 months

  2. ΔCAL - 9 months

    Change of Clinical Attachment Level, measured in milimetres

    Measured: 9 months

  3. FMPS

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

    Measured: 3, 6, 9, 12 months

  4. FMBOP

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

    Measured: 3, 6, 9, 12 months

  5. ΔREC

    Change in Recession , measured in milimetres

    Measured: 3, 6, 9, 12 months

  6. ΔPPD

    Change in Periodontal Pocket Depth, measrued in millimetres

    Measured: 6, 9, 12 months

  7. Mob

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

    Measured: 3, 6, 9, 12 months

  8. EWHI

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

    Measured: 3, 6, 9, 12 months

  9. ΔINFRA

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

    Measured: 3, 6, 9, 12 months

  10. TIME

    Time for the surgery , measured in minutes

    Measured: Measured throughout procedure

  11. % of sites achieving therapeutic endpoints

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

    Measured: 6, 9, 12 months

  12. 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.

    Measured: Baseline, 3, 6, 9, 12 months

  13. Intra-operative Discomfort

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

    Measured: 14 days

  14. Daily intake of analgesia

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

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start2 Jan 2026 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blinded randomized non-inferiority controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978036
Sponsor's protocol ID
P&ID2025_02
Acronym
EAFAR
Status last verified
May 2025
First submitted
10 May 2025
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Ho DKL, Fok MR, Lau XW, Leung WK, Zhang JC, Pelekos G. Single-blinded randomized non-inferiority controlled clinical trial comparing endoscope-assisted flapless approach versus papillary preservation technique in periodontal regeneration of intrabony periodontal defects: study protocol. Trials. 2026 Feb 26;27(1):263. doi: 10.1186/s13063-026-09581-y.

    PubMed 41749350

Questions about this trial

What is this clinical trial studying?

A study testing Flapless periodontal regeneration with EMD + EASD and Periodontal regeneration with EMD + PPT in people with Periodontitis and Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa R Fok, PhD (+85228590495, melfok@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ΔCAL - 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06978036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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