Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects

Periodontal Diseases Clinical Trial

Official title:

Clinical Outcomes of the Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects: A Randomised-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923465
• Other study ID #: AslanPPC_RCT_01
• Status: Completed
• Phase: N/A
• Start date: April 4, 2015
• Est. completion date: June 4, 2019

Study information

• Verified date: July 2023
• Source: Dr. Aslan Private Perio Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 4, 2019
• Est. primary completion date: September 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Systemically healthy

• Clinical diagnosis of advanced periodontitis

• Having one isolated intrabony defect with probing depth (PD) =7 mm, clinical attachment level (CAL) =8 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth.

• Full-mouth plaque score (FMPS) =20%.

• Full-mouth bleeding score (FMBS) =20%.

Exclusion Criteria:

• Smokers

• Patients with known systemic diseases such as diabetes and cardiovascular diseases or using medications that affect periodontal tissues, pregnant or lactating women

• One-wall intrabony defects

• Defects that involve buccal and lingual sites

• Presence of inadequate endodontic treatment and/or restoration in the relevant teeth.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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.

Device:
• EMD application
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
Following the application of EMD, filling the bone defect with bone substitutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Aslan Private Perio Center

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level (CAL) gain	CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe	1-year
Secondary	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).	1-week after surgery