Peri-Implant Soft Tissue Integration in Humans: Influence of Material

The purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Mucointegration

Detailed Description

After being informed about the study and potential risks, all participants give written informed consent and eligibility for study entry.

The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.

After 8 weeks of healing, biopsy are separated in two groups according to the removal:

• if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
• if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémentine Canuel, MsD; Phone Number: +33679097264; Email: clementine.canuel@hotmail.fr

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • Clémentine Canuel
    • Contact: Clémentine Canuel, MsD; Phone Number: +33679097264; Email: clementine.canuel@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants have to voluntarily sign the informed consent form before any study related action
• Patients aged 18 or over
• Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
• Men/women
• Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
• Patients requiring a replacement of missing teeth; the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation
• At least 3 mm of fibrous mucosa in the bucco-lingual dimension
• Full mouth plaque score (FMPI) lower than or equal to 25%
• At least a diameter of 4 mm for the implant (regular diameter)

Exclusion Criteria:

• Autoimmune disease requiring medical treatment
• Medical conditions requiring prolonged use of steroids
• Use of Bisphosphonates intravenously or more than 3 years of oral use
• Infection (local or systemic) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
• Current pregnancy or breastfeeding women
• Alcoholism or chronical drug abuse
• Immunocompromised patients
• Uncontrolled diabetes
• Smokers
• Prisoners
• Implant's diameter under 4 mm (narrow implant)
• Conditions or circumstances, in the opinion of the investigator, which would prevent completion of the study or interference with analysis of study results, such as history of non-compliance, or unreliability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultra-polished zirconia abutment	Other: Mucointegration; Placement of abutment on a dental implant to study mucointegration
Experimental: Machined zirconia abutment	Other: Mucointegration; Placement of abutment on a dental implant to study mucointegration
Active Comparator: Titanium abutment	Other: Mucointegration; Placement of abutment on a dental implant to study mucointegration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunohistology	Analysis of the pro-inflammatory cells and vascularisation of the soft tissue + analysis of the percentage of cells adhesion on the abutment	8 weeks of healing
Histomorphometry	Height measure of biological width (sulcus depth, epithelial and connective adhesion)	8 weeks of healing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical observations	plaque score, inflammation	baseline + 8 weeks of healing

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Actual): June 18, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022/189; B7072022000023 (Other Identifier: Comité de étique Hospitalo-Facultaire Universitaire de Liege)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No