NCT03923465

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2019

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.5 years

First QC Date

April 15, 2019

Last Update Submit

July 18, 2023

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post-surgical discomfort

    1-week after surgery

Study Arms (2)

EPP with EMD+BS

ACTIVE COMPARATOR

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) techniqueDevice: EMD applicationDevice: Bone substitutes application

EPP without EMD+BS

OTHER

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

Interventions

Procedure: Periodontal surgery with entire papilla preservation (EPP) techniquePROCEDURE

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.

EPP with EMD+BSEPP without EMD+BS
EMD applicationDEVICE

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
EPP with EMD+BS
Bone substitutes applicationDEVICE

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

EPP with EMD+BS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28196163BACKGROUND

  • 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.

    PMID: 28727170BACKGROUND

  • 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.

    PMID: 31925811DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Serhat Aslan, DDS, PhD

    Private Office Dr. Aslan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 22, 2019

Study Start

April 4, 2015

Primary Completion

September 16, 2018

Study Completion

June 4, 2019

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share