NCT05458271 - Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site. | Crick | Crick

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

N/AActive Not RecruitingNCT05458271

University of Florence100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Edentulous Alveolar Ridge Atrophy Soft Tissue Augmentation At Dental Implants

Interventions

VCMXDEVICE

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

CTGPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Università degli Studi di Firenze

Florence, FI, Italy

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100))

Time frame: Immediately After Surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 1 week After surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 2 weeks After surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 4 weeks After surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 3 months After surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 6 months after surgery

PROMs

After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)

Time frame: 12 months after surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: At Baseline

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 1 week After surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 2 weeks After surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 4 weeks After surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 3 months After surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 6 months after surgery

KT

The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe

Time frame: 12 months after surgery