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

Phase 4

Recruiting

• Conditions: Mucogingival Deformity on Edentulous Ridge; Edentulous Alveolar Ridge; Soft Tissue Atrophy
• Interventions: Procedure: Implant Placement; Procedure: Soft Tissue graft augmentation

• Registration Number: NCT04766255
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-23
• Study Start: 2021-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Implant Placement	Implant placement and prosthetic rehabilitation of the missing tooth
SCTG group	Soft Tissue graft augmentation	Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.
CM group	Soft Tissue graft augmentation	Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.
PADM group	Implant Placement	Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.
PADM group	Soft Tissue graft augmentation	Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.
SCTG group	Implant Placement	Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.
CM group	Implant Placement	Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.

Primary Outcome Measures

Name	Time	Method
soft tissue volume gain	after 3 months	Optical scans superposition

Secondary Outcome Measures

Name	Time	Method
soft tissue volume stability	after 15 months	Optical scans superposition
Width of keratinized tissue (KT)	at baseline, after 12 weeks and after 15 months.	in the implant area (implant and both teeth nxt to it). Measured in the medial buccal point of the tooth/implant. Distance from mucogingival junction to the most apical portion of the crest of the marginal gingiva. The mucogingival junction will be identified by the roll technique, wherein the mucosa is rolled until the non-movable portion of the attached keratinized tissue is seen
Bleeding on probing (BI)	at baseline, after 12 weeks and after 15 months.	Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After a gentle probing if the gingiva bleeds will be positive.
Probing depth (PD)	at baseline, after 12 weeks and after 15 months.	in the implant area (implant and both tooth next to it). Distance from the gingival margin to the bottom of the gingival sulcus using periodontal probe (UNC 15). Measured in 6 points: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual.
Patient reported outcome measures (PROMs)	after the surgery procedures (baseline) and after 7 days (suture removal)	patient pain/discomfort will be evaluated (a questionnaire will be provided to each patient after all the surgery procedures and it will be recollected the day of suture removal)
Plaque index (PI)	at baseline, after 12 weeks and after 15 months.	Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972)
Phenotype evaluation (PT)	at baseline, after 12 weeks and after 15 months.	the gingival biotype was categorized as thin or thick based on the transparency of a periodontal probe (CP15 UNC; Hu-Friedy, Chicago, IL, USA) through the soft tissues while probing the buccal sulcus of the contra-lateral tooth (17-19)
Pink Esthetic Score (PES)	After 2 weeks of the definite crown placement (around 16 months)	will be registered to obtain information related to the papilla, the level of soft-tissue margin, the alveolar process, the color, contour and texture of the same soft tissue

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain