Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

NCT04766255 · tracked via the Priya Life Science Spain tracker

Sponsor

Universitat Internacional de Catalunya

Phase

Phase 4

Started

2021-05-01

Last updated

2024-12-11

Condition(s) studied

Soft Tissue AtrophyMucogingival Deformity on Edentulous RidgeEdentulous Alveolar Ridge

Investigational drug(s) / intervention(s)

Soft Tissue graft augmentationImplant Placement

Soft Tissue graft augmentation: Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture

Implant Placement: A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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 outcome measure(s)

soft tissue volume gain — after 3 months
Optical scans superposition

Trial sites (1)

Facility	City	Region	Status
Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04766255 on ClinicalTrials.gov ↗ ← All trials in Spain