Periodontal Regeneration, Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery, Periodontitis
Conditions
Keywords
Periodontitis, Intrabondy defects, Perioscope, Perioscopy, endoscope-assisted, regeneration, papilla preservation, enamel matrix derivative
Brief 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. 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.
Interventions
PROCEDUREFlapless periodontal regeneration with EMD + EASD
Periodontal regneration with EMD in conjuction with Endoscope-assisted subgingival debridement
PROCEDUREPeriodontal regeneration with EMD + PPT
Periodontal regneration with EMD in conjunction with periodontal surgery using Papilla Presevation Technique
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-blinded randomized non-inferiority controlled clinical trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔCAL - 12 months | 12 months | Change of Clinical Attachment Level measured in millimetres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔCAL - 9 months | 9 months | Change of Clinical Attachment Level, measured in milimetres |
| FMPS | 3, 6, 9, 12 months | Modified O'Leary Full Mouth Plaque Score, measured in percentage |
| FMBOP | 3, 6, 9, 12 months | Full Mouth Bleeding On Probing (excluding teeth under investigation), measured in percentage |
| ΔREC | 3, 6, 9, 12 months | Change in Recession , measured in milimetres |
| ΔPPD | 6, 9, 12 months | Change in Periodontal Pocket Depth, measrued in millimetres |
| Mob | 3, 6, 9, 12 months | Tooth Mobility Index (Miller 1938), the higher the number the greater the mobility |
| ΔCAL - 6 months | 6 months | Change of Clinical Attachment Level, measured in milimetres |
| ΔINFRA | 3, 6, 9, 12 months | Change of depth of the intrabony defect , measured on radiographs in millimetres. |
| TIME | Measured throughout procedure | Time for the surgery , measured in minutes |
| % of sites achieving therapeutic endpoints | 6, 9, 12 months | % of sites achieving therapeutic endpoints (i.e. no PPD \> 4mm with bleeding and no deep residual pocket PPD \>5mm) |
| Patient-reported outcome measurements | 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. |
| Intra-operative Discomfort | 14 days | 100mm Visual Analog Scale is used to measure the intra-operative pain and discomfort during the test/control therapy. |
| Daily intake of analgesia | 14 days | Daily intake of analgesia will be recorded on the first 14 days after the operation. |
| EWHI | 3, 6, 9, 12 months | Early Wound Healing Index (Wachtel et al., 2003), a lower score signifies a better healing |
Countries
Hong Kong
Contacts
Primary ContactMelissa R Fok, PhD
Backup ContactAmy Wong
Outcome results
None listed