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

NCT05805033 | Recruiting

• 2 other identifiers: 2022/189B7072022000023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Histomorphometry

  Height measure of biological width (sulcus depth, epithelial and connective adhesion)

  8 weeks of healing

• 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

Study Arms (3)

Ultra-polished zirconia abutment

EXPERIMENTAL

Other: Mucointegration

Machined zirconia abutment

EXPERIMENTAL

Other: Mucointegration

Titanium abutment

ACTIVE COMPARATOR

Other: Mucointegration

Interventions

Mucointegration OTHER

Placement of abutment on a dental implant to study mucointegration

Machined zirconia abutment; Titanium abutment; Ultra-polished zirconia abutment

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (1)

Clémentine Canuel

Liège, 4000, Belgium

RECRUITING

Central Study Contacts

Clémentine Canuel, MsD

CONTACT

+33679097264; clementine.canuel@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 2nd year resident in periodontology, oral and implant surgery

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: September 22, 2023
• Primary Completion: June 18, 2024
• Study Completion: October 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

BE (1)