An interventional study of Procedure: Periodontal surgery with entire papilla preservation (EPP) technique and EMD application in Periodontal Diseases, sponsored by Dr. Aslan Private Perio Center. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Dr. Aslan Private Perio Center · Not applicable, Interventional, and Treatment
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →This is the only study on the registry with Dr. Aslan Private Perio Center as lead sponsor.
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Exclusion Criteria:
Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes
Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique · Device: EMD application · Device: Bone substitutes application
Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes
Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique
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.
Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.
Also known as: Amelogenins application
Following the application of EMD, filling the bone defect with bone substitutes.
Clinical attachment level (CAL) gain
CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe
Time frame: 1-year
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).
Time frame: 1-week after surgery
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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