Clinical trial NCT04766255: Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Official title: Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Soft Tissue Atrophy
Mucogingival Deformity on Edentulous Ridge
Edentulous Alveolar Ridge
Keywords: soft tissue graft
acellular dermal graft
collagen matrix
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled randomized prospective clinical study.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.


Eligibility criteria: Inclusion Criteria:

Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.

* The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
* The implant must be located between 2 fixed reference points (i.e. clinical crowns).
* Anterior and premolar teeth (from premolar to premolar).
* Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
* Palate must have ≥2mm of thickness at premolar area.
* Full mouth plaque and bleeding score \<20%.

Exclusion Criteria:

* Pregnant or lactation.
* Active periodontal disease.
* Previous soft tissue augmentation in the area.
* Need of guided bone regeneration (GBR) during or after the placement of the implant.
* Heavy smokers (\> 10 cigarettes per day).
* Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
* Allergy to non-steroidal anti-inflammatory drugs.
* Patients taking medications that cause gingival enlargement.

Primary outcomes:
measure: soft tissue volume gain
timeFrame: after 3 months
Secondary outcomes:
measure: soft tissue volume stability
timeFrame: after 15 months
measure: Plaque index (PI)
timeFrame: at baseline, after 12 weeks and after 15 months.
measure: Bleeding on probing (BI)
timeFrame: at baseline, after 12 weeks and after 15 months.
measure: Probing depth (PD)
timeFrame: at baseline, after 12 weeks and after 15 months.
measure: Width of keratinized tissue (KT)
timeFrame: at baseline, after 12 weeks and after 15 months.
measure: Phenotype evaluation (PT)
timeFrame: at baseline, after 12 weeks and after 15 months.
measure: Patient reported outcome measures (PROMs)
timeFrame: after the surgery procedures (baseline) and after 7 days (suture removal)
measure: Pink Esthetic Score (PES)
timeFrame: After 2 weeks of the definite crown placement (around 16 months)
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Andres Pascual La Rocca, DDS
role: PRINCIPAL_INVESTIGATOR
References: