Menu
Recruiting NCT04766255

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

Phase IV Interventional Soft Tissue Atrophy Mucogingival Deformity on Edentulous Ridge Edentulous Alveolar Ridge

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soft Tissue graft augmentation, Implant Placement.
Who it may be relevant to
Registry conditions: Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Procedure 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 indica
  • Procedure 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 h

Primary outcome measures

  • soft tissue volume gain [Time frame: after 3 months]
Secondary outcome measures (8)
  • soft tissue volume stability [Time frame: after 15 months]
  • Plaque index (PI) [Time frame: at baseline, after 12 weeks and after 15 months.]
  • Bleeding on probing (BI) [Time frame: at baseline, after 12 weeks and after 15 months.]
  • Probing depth (PD) [Time frame: at baseline, after 12 weeks and after 15 months.]
  • Width of keratinized tissue (KT) [Time frame: at baseline, after 12 weeks and after 15 months.]
  • Phenotype evaluation (PT) [Time frame: at baseline, after 12 weeks and after 15 months.]
  • Patient reported outcome measures (PROMs) [Time frame: after the surgery procedures (baseline) and after 7 days (suture removal)]
  • Pink Esthetic Score (PES) [Time frame: After 2 weeks of the definite crown placement (around 16 months)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universitat Internacional de Catalunya — Sant Cugat del Vallès

Identifiers

NCT: NCT04766255 · PER-ECL-2017-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗