Clinical trial NCT06335628: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
Official title: Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Connective Tissue Graft
Volume Collagen Matrix Xenograft
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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

Primary outcomes:
measure: Volumetric dimensional changes
timeFrame: 0-5 years
Secondary outcomes:
measure: Clinical: PPD
timeFrame: 0-5 years
measure: Clinical BoP
timeFrame: 0-5 years
measure: Clinical: Suppuration
timeFrame: 0-5 years
measure: Clinical: Mucosa
timeFrame: 0-5 years
measure: Clinical: ktw
timeFrame: 0-5 years
measure: Clinical: Mobility
timeFrame: 0-5 years
measure: Clinical: Thickness
timeFrame: 0-5 years
measure: Clinical: Contributing factors
timeFrame: 0-5 years
measure: Patient-reported satisfaction
timeFrame: 0-5 years
measure: Patient-reported esthetics
timeFrame: 0-5 years
measure: Patient-reported discomfort
timeFrame: 0-5 years
measure: Patient-reported pain
timeFrame: 0-5 years
measure: Prosthetics Survival
timeFrame: 0-5 years
measure: Prosthetics Success
timeFrame: 0-5 years
measure: Prosthetics Complications
timeFrame: 0-5 years
measure: Prosthetics PES-WES
timeFrame: 0-5 years
measure: Prosthetics: Occlusal
timeFrame: 0-5 years
measure: Prosthetics: Interproximal
timeFrame: 0-5 years
measure: Radiographics BL
timeFrame: 0-5 years
measure: Radiographics PP
timeFrame: 0-5 years
measure: Radiographics distance
timeFrame: 0-5 years
measure: Radiographics Contacts
timeFrame: 0-5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Manrique Fonseca, DDS
role: PRINCIPAL_INVESTIGATOR
References: