Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

Not Applicable

Recruiting

• Conditions: Volume Collagen Matrix Xenograft; Connective Tissue Graft
• Interventions: Device: Geistlich Fibro-Gide®

• Registration Number: NCT06335628
• Lead Sponsor: University of Bern

Brief Summary

The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Study Start: 2024-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Informed Consent signed by the subject
• Age ≥ 18 years
• Willingness to sign informed consent and to participate in the study
• Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
• Tooth gap of ≥ 8 mm.
• Presence of natural or artificial opposing dentition
• Sufficient vertical interocclusal space of an implant restoration (7mm)
• Bounded by natural and periodontally stable teeth
• Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

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Exclusion Criteria

• Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
• Severe bruxism, clenching habits, or presence of oro-facial pain
• Uncontrolled diabetes mellitus (HbA1c >7.0)
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Any active oral or systemic acute infections
• Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
• Severe hematologic disorders
• Any other diseases or medications that may compromise normal wound healing
• Pregnancy or nursing mother
• Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
• Vulnerable subjects
• Known or suspected non-compliance
• Drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
• Enrolment of the PI, his/her family members, employees and other dependent persons

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®	Geistlich Fibro-Gide®	The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.

Primary Outcome Measures

Name	Time	Method
Volumetric dimensional changes	0-5 years	To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX

Secondary Outcome Measures

Name	Time	Method
Clinical: PPD	0-5 years	Clinical: Probing depth in neighboring teeth
Clinical BoP	0-5 years	Clinical: Bleeding on probing
Clinical: Thickness	0-5 years	Clinical: Mucosal thickness
Clinical: Contributing factors	0-5 years	Clinical: Presence of local contributing factors
Patient-reported satisfaction	0-5 years	Questionnaire: Overall patient satisfaction with the treatment provided
Patient-reported esthetics	0-5 years	Questionnaire: Esthetics
Clinical: Suppuration	0-5 years	Clinical: Suppuration on probing
Clinical: Mucosa	0-5 years	Clinical: Apical migration of the marginal mucosa
Clinical: ktw	0-5 years	Clinical: Keratinized tissue width
Clinical: Mobility	0-5 years	Clinical: Mobility
Patient-reported discomfort	0-5 years	Questionnaire: Discomfort
Patient-reported pain	0-5 years	Questionnaire: Pain
Prosthetics Survival	0-5 years	Prosthetic-related: Fixed dental prostheses survival rates
Prosthetics Success	0-5 years	Prosthetic-related: Fixed dental prostheses success rates
Prosthetics Complications	0-5 years	Prosthetic-related: Technical complications
Prosthetics PES-WES	0-5 years	Prosthetic-related: Esthetic score (PES-WES)
Prosthetics: Occlusal	0-5 years	Prosthetic-related: Occlusal contacts (static and dynamic)
Prosthetics: Interproximal	0-5 years	Prosthetic-related: Presence of interproximal contacts.
Radiographics BL	0-5 years	Marginal bone levels
Radiographics PP	0-5 years	Periapical pathosis
Radiographics distance	0-5 years	Distance from the adjacent teeth/implants
Radiographics Contacts	0-5 years	Presence of open contacts

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland