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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03923465

Recruitment Status Completed

First Posted April 22, 2019

Last update posted July 5, 2019

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.

  • Condition or Disease:Periodontal Diseases
  • Intervention/Treatment: Device: Bone substitutes application
    Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique
    Device: EMD application
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: April 2015
  • Actual Primary Completion Date: September 2018
  • Actual Study Completion Date: June 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: EPP with EMD+BS
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
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.

Device: Bone substitutes application
Following the application of EMD, filling the bone defect with bone substitutes.
Other: EPP without EMD+BS
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.
Outcome Measures
  • Primary Outcome Measures: 1. Clinical attachment level (CAL) gain [ Time Frame: 1-year ]
    CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe
  • Secondary Outcome Measures: 1. Post-surgical discomfort [ Time Frame: 1-week after surgery ]
    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).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Dr. Aslan Private Perio Center

Investigators

Principal Investigator: Serhat Aslan, DDS, PhD Private Office Dr. Aslan

More Information