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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Geistlich Fibro-Gide®

    Device

    Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Group A: Connective Tissue Graft (CTG)No intervention 0 interventions
Group B: Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Volumetric dimensional changes

To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX

Time frame
0-5 years

Secondary outcomes

1

Clinical: PPD

Clinical: Probing depth in neighboring teeth

Time frame
0-5 years
2

Clinical BoP

Clinical: Bleeding on probing

Time frame
0-5 years
3

Clinical: Suppuration

Clinical: Suppuration on probing

Time frame
0-5 years
4

Clinical: Mucosa

Clinical: Apical migration of the marginal mucosa

Time frame
0-5 years

Other outcomes

Sponsors and contacts

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