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

NCT06618560 | Not Yet Recruiting DMC

• 1 other identifier: E-66291034-202.3.02-2928
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

enamel matrix proteins; hyaluronic acid; peri-implantitis; non-surgical treatment

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant pocket depth

  Peri-implant pocket depth (PPD) values will be measured at six sites of each implant. The mean PPD change will be calculated as the difference between the 12-month follow-up PPD relative to the baseline PPD.

  12 months after the treatment

Secondary Outcomes (4)

• Treatment success (%)

  12 months after the treatment

• Disease resolution (%)

  12 months after the treatment

• Oral Health Impact Profile 14

  12 months after the treatment

• Post-treatment pain

  12 months after the treatment

Study Arms (3)

Test Group 1: EMD group

ACTIVE COMPARATOR

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: Enamel Matrix Derivative application

Test Group 2: HA group

ACTIVE COMPARATOR

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.

Device: Hyaluronic Acid (HA)

Control group

PLACEBO COMPARATOR

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.

Procedure: Control

Interventions

Enamel Matrix Derivative application DEVICE

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.

Test Group 1: EMD group

Hyaluronic Acid (HA) DEVICE

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.

Test Group 2: HA group

Control PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy and ≥18 years of age,
• Implants with an SLA® or SLActive® surface (Straumann Dental Implant System, Institute Straumann AG) have been in function for more than 1 year,
• Implant-supported prostheses accessible for self-performed plaque control and submarginal instrumentation,
• Absence of implant mobility.

You may not qualify if:

• Full-mouth plaque score (FMPS) \> 20%
• Full-mouth bleeding score (FMBS) \> 20%
• Cigarette smoking \> 10 cig./day,
• Diagnosed with active periodontal disease,
• Having acute or chronic medical conditions or undergoing medications, such as intravenous amino-bisphosphonates, immunosuppressive drugs, and chemotherapy, that could interfere with the treatment outcome,
• Receiving antibiotic treatment in the previous 3 months.

Sponsors & Collaborators

• Gazi University: lead

Related Publications (3)

• Soriano-Lerma A, Magan-Fernandez A, Gijon J, Sanchez-Fernandez E, Soriano M, Garcia-Salcedo JA, Mesa F. Short-term effects of hyaluronic acid on the subgingival microbiome in peri-implantitis: A randomized controlled clinical trial. J Periodontol. 2020 Jun;91(6):734-745. doi: 10.1002/JPER.19-0184. Epub 2019 Oct 18.

  PMID: 31577041 BACKGROUND

• Isehed C, Svenson B, Lundberg P, Holmlund A. Surgical treatment of peri-implantitis using enamel matrix derivative, an RCT: 3- and 5-year follow-up. J Clin Periodontol. 2018 Jun;45(6):744-753. doi: 10.1111/jcpe.12894. Epub 2018 Apr 26.

  PMID: 29574866 BACKGROUND

• Khan SN, Koldsland OC, Roos-Jansaker AM, Wohlfahrt JC, Verket A, Mdala I, Magnusson A, Salvesen E, Hjortsjo C. Non-surgical treatment of mild to moderate peri-implantitis with an oscillating chitosan brush or a titanium curette-12-month follow-up of a multicenter randomized clinical trial. Clin Oral Implants Res. 2023 Jul;34(7):684-697. doi: 10.1111/clr.14078. Epub 2023 May 3.

  PMID: 37139538 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sila Cagri Associate Professor, PhD

CONTACT

+90 312 2034232; silaisler@gazi.edu.tr

Andrea Roccuzzo, PhD

CONTACT

andrea.roccuzzo@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share