Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to investigate the clinical efficacy of entire papilla preservation technique with and without the adjunct of amelogenins (EMD) and bone substitutes.
The present study is designed as a single-centre, parallel group, randomized, controlled clinical trial comparing the efficacy of EPP with or without biomaterials. Each patient will contribute with a single intrabony defect. Three months after completion of initial periodontal therapy, all the experimental sites will be accessed with the "EPP" technique (Aslan et al., 2017a) and carefully debrided. EDTA gel will be applied on the instrumented root surfaces. A combination of EMD and deproteinized bovine-derived bone substitute will be applied in the test group (EPP EMD + BS), while the control group (EPP) will not receive any regenerative biomaterial. Patients will be enrolled in a stringent maintenance programme with recalls on a weekly basis for the first month and then monthly controls for professional tooth cleaning up to 1 year. Clinical parameters will be recorded immediately before regenerative surgery (baseline) and 12 months after the regenerative periodontal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPP with EMD+BS | Active Comparator | Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes |
|
| EPP without EMD+BS | Other | Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Periodontal surgery with entire papilla preservation (EPP) technique | Procedure | After local anesthesia injection an modified flap is designed according to minimally invasive microsurgical techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) gain | CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical discomfort | Post-surgical discomfort will be measured on a visual analog scale (VAS) and reported in millimeters. The subjects will be instructed to mark their level of pain on a line. The average change in discomfort level will be determined and compared between the two arms. A visual analogue scale (VAS) of 100 mm long will be used to evaluate the degree of discomfort (0=no pain/hardship; 100=unbearable pain/hardship). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Serhat Aslan, DDS, PhD | Private Office Dr. Aslan | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28196163 | Background | Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584. | |
| 28727170 | Background | Aslan S, Buduneli N, Cortellini P. Entire papilla preservation technique in the regenerative treatment of deep intrabony defects: 1-Year results. J Clin Periodontol. 2017 Sep;44(9):926-932. doi: 10.1111/jcpe.12780. Epub 2017 Aug 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| EMD application | Device | Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface. |
|
|
| Bone substitutes application | Device | Following the application of EMD, filling the bone defect with bone substitutes. |
|
| 1-week after surgery |
| 31925811 | Derived | Aslan S, Buduneli N, Cortellini P. Clinical outcomes of the entire papilla preservation technique with and without biomaterials in the treatment of isolated intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):470-478. doi: 10.1111/jcpe.13255. Epub 2020 Feb 3. |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided