Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.

NCT05458271 | Active Not Recruiting DMC

• 1 other identifier: VCMX vs CTG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance. The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.

Conditions

Edentulous Alveolar Ridge Atrophy; Soft Tissue Augmentation At Dental Implants

Outcome Measures

Primary Outcomes (7)

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  Immediately After Surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  1 week After surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  2 weeks After surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  4 weeks After surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  3 months After surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  6 months after surgery

• GT

  Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

  12 months after surgery

Secondary Outcomes (14)

• PROMs

  Immediately After Surgery

• PROMs

  1 week After surgery

• PROMs

  2 weeks After surgery

• PROMs

  4 weeks After surgery

• PROMs

  3 months After surgery

Study Arms (2)

VCMX

EXPERIMENTAL

All patients will be treated by scaling/root planing to obtain infection control if needed. In addition, patients will receive oral hygiene instructions. The test group will be treated with add of VCMX. Following the local anesthesia, a split thickness flap will be raised-up to uncover the implant screw. Care will be taken to preserve pre-existing KT amount. A mesio-distal and apical partial thickness dissection will be performed to release residual muscle tension and allow the passive apical displacement of the flap. The randomisation envelope will be then opened. In test group the VCMX will be gently shaped and secured under the flap with suture. Care will be applied to completely cover the xenograft.

Device: VCMX

CTG

ACTIVE COMPARATOR

The control group patients will be treated by flap surgery with add of CTG. In the control group (APF) a CTG harvested from palate will be secured under the flap with suture.

Procedure: CTG

Interventions

VCMX DEVICE

A flap will be raised and VCMX will be placed in order to increase the soft tissue volume

VCMX

CTG PROCEDURE

A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume

CTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• No systemic diseases or pregnancy.
• Self-reported smoking ≤10 cigarettes/day.
• No probing depths ≥5 mm
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤15% (measured at four sites per tooth).
• Single dental implant with a scheduled for soft tissue augmentation procedure at the time of uncovering.
• Need of soft tissue augmentation for aesthetic purpose and/or functional reasons
• No previous soft tissue augmentation procedure at experimental site.

You may not qualify if:

• General contraindications for dental and/or surgical treatments
• Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
• Inflammatory and autoimmune disease of oral cavity
• History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
• Radiotherapy of head area
• Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
• Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
• Untreated acute periodontal disease
• Patients who smoke more than 10 cigarettes/day will be excluded from the study
• Diabetes
• Allergy to the collagen
• Pregnant or lactating women
• Women of child bearing age, not using a highly effective method of birth control
• Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Università degli Studi di Firenze

Florence, FI, 50134, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Examiners will be blinded throughout all experimental procedures for all measurements. Operators will be blinded until they will raise the flap and screw the healing abutment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 14, 2022
• Study Start: July 31, 2022
• Primary Completion: October 31, 2023
• Study Completion: June 25, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

IT (1)