The University of Hong Kong
Hong Kong
NCT Number: NCT06978036
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.
Trial opening soon.
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Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique
Time frame: 12 months
Change of Clinical Attachment Level measured in millimetres
Time frame: 6 months
Change of Clinical Attachment Level, measured in milimetres
Time frame: 9 months
Change of Clinical Attachment Level, measured in milimetres
Time frame: 3, 6, 9, 12 months
Modified O'Leary Full Mouth Plaque Score, measured in percentage
Time frame: 3, 6, 9, 12 months
Full Mouth Bleeding On Probing (excluding teeth under investigation), measured in percentage
Time frame: 3, 6, 9, 12 months
Change in Recession , measured in milimetres
Time frame: 6, 9, 12 months
Change in Periodontal Pocket Depth, measrued in millimetres
Time frame: 3, 6, 9, 12 months
Tooth Mobility Index (Miller 1938), the higher the number the greater the mobility
Time frame: 3, 6, 9, 12 months
Early Wound Healing Index (Wachtel et al., 2003), a lower score signifies a better healing
Time frame: 3, 6, 9, 12 months
Change of depth of the intrabony defect , measured on radiographs in millimetres.
Time frame: Measured throughout procedure
Time for the surgery , measured in minutes
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)
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.
Time frame: 14 days
100mm Visual Analog Scale is used to measure the intra-operative pain and discomfort during the test/control therapy.
Time frame: 14 days
Daily intake of analgesia will be recorded on the first 14 days after the operation.
Contact information is provided by the study sponsor or research team.
Amy Wong
CONTACT
Melissa R Fok, PhD
CONTACT
The University of Hong Kong
Other
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
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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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