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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
Dr. Aslan Private Perio Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 15, 2019
    Last Updated
    July 18, 2023
    Sponsor
    Dr. Aslan Private Perio Center
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    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

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

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