Status:
RECRUITING
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Lead Sponsor:
Universitat Internacional de Catalunya
Conditions:
Soft Tissue Atrophy
Mucogingival Deformity on Edentulous Ridge
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04766255
Start Date
May 1 2021
End Date
December 30 2026
Last Update
December 11 2024
Active Locations (1)
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1
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195