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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flapless EASD + EMD | Experimental | Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement |
|
| PPT + EMD | Active Comparator | Periodontal regneration with periodontal surgery using Papilla Presevation Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flapless periodontal regeneration with EMD + EASD | Procedure | Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement |
|
| Measure | Description | Time Frame |
|---|---|---|
| ΔCAL - 12 months | Change of Clinical Attachment Level measured in millimetres | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pre-study period
During study period -Non-compliance with study protocol
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa R Fok, PhD | Contact | +85228590495 | melfok@hku.hk | |
| Amy Wong | Contact | +85228590485 | ammmymei@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41749350 | Derived | 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. |
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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.
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Single-blinded randomized non-inferiority controlled clinical trial
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| Periodontal regeneration with EMD + PPT | Procedure | Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique |
|
| 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C092710 | emerin |
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