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Completed

NCT Number: NCT03923465

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

EMD application

Device

Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.

Other names: Amelogenins application

Bone substitutes application

Device

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Dr. Aslan Private Perio Center

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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