Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Procedure: Periodontal surgery with entire papilla preservation (EPP) technique
EMD application
Bone substitutes application
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
EPP with EMD+BS
EPP without EMD+BS
Arm Description
Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes
Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes
Outcomes
Primary Outcome Measures
Clinical attachment level (CAL) gain
CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03923465
First Posted
April 15, 2019
Last Updated
July 18, 2023
Sponsor
Dr. Aslan Private Perio Center
1. Study Identification
Unique Protocol Identification Number
NCT03923465
Brief Title
Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2015 (Actual)
Primary Completion Date
September 16, 2018 (Actual)
Study Completion Date
June 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Aslan Private Perio Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPP with EMD+BS
Arm Type
Active Comparator
Arm Description
Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes
Arm Title
EPP without EMD+BS
Arm Type
Other
Arm Description
Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes
Intervention Type
Procedure
Intervention Name(s)
Procedure: Periodontal surgery with entire papilla preservation (EPP) technique
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EMD application
Other Intervention Name(s)
Amelogenins application
Intervention Description
Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.
Intervention Type
Device
Intervention Name(s)
Bone substitutes application
Intervention Description
Following the application of EMD, filling the bone defect with bone substitutes.
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL) gain
Description
CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Post-surgical discomfort
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serhat Aslan, DDS, PhD
Organizational Affiliation
Private Office Dr. Aslan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28196163
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.
Results Reference
background
PubMed Identifier
28727170
Citation
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.
Results Reference
background
PubMed Identifier
31925811
Citation
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.
Results Reference
derived
Learn more about this trial
Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects
We'll reach out to this number within 24 hrs