MedTrace Logo

Effect of Enamel Matrix Derivative or Hyaluronic Acid on Non-Surgical Treatment of Peri-Implantitis

NCT06618560 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-01

No results posted yet for this study

Summary

The aim of the present randomized controlled clinical study is to compare the clinical, radiographic, and patient-centered efficacy of adjunctive application of either enamel matrix derivative (EMD) or hyaluronic acid (HA) gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period.

Therefore, the following question related to the study is raised:

• Does the adjunctive local application of EMD or HA to non-surgical submucosal mechanical treatment of peri-implantitis result in better clinical, radiographic, and patient-centered outcomes compared to non-surgical therapy alone?

A total of 60 patients referred to the Gazi University Department of Periodontology, will be randomly assigned to receive the local application of EMD or HA in combination with non-surgical submucosal mechanical treatment of peri-implantitis or non-surgical therapy alone. Clinical measurements will be recorded at baseline, 3, 6, and 12 months after surgeries. Patient oral health related to the treatment procedures using a written questionnaire \[Oral Health Impact Profile (OHIP-14)\] and post-treatment pain and overall patient satisfaction about treatment modalities responses will be evaluated prior to treatment and 3, 6, and 12 months following therapy.

Conditions

  • Peri-implantitis

Interventions

DEVICE

Enamel Matrix Derivative application

After submarginal instrumentation (i.e., titanium curettes plus oscillating chitosan brush), implant surfaces will be conditioned for 2 min with 24% ethylene-diaminetetraacetate EDTA (PrefGel®, Institut Straumann AG). Then, the sites will be completely rinsed with saline solution and thoroughly dried with air. Repeated irrigation and air-drying will be done in the area until complete bleeding control with sterile gauzes. Then EMD (Emdogain®, Institut Straumann AG) will be gently applied with a blunt-tipped sterile syringe until overflowing from the mucosal margin.

DEVICE

Hyaluronic Acid (HA)

After submarginal instrumentation of the implant surface (i.e., titanium curettes plus oscillating chitosan brush), the cross-linked hyaluronic acid gel composed of a mixture of cross-linked (1.6%) and natural (0.2%) will be will be implemented to the peri-implant pockets.

PROCEDURE

Control

Implants allocated to the control group will be treated with the same sub-marginal instrumentation (i.e., titanium curettes plus oscillating chitosan brush). Implant surface will be irrigated with with sterile saline.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-01-15
Completion
2026-01-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618560 on ClinicalTrials.gov