Back to resultsCross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft at Implant Site.
Primary Purpose
Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation at Dental Implants
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
VCMX
CTG
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge Atrophy
Eligibility Criteria
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
Sites / Locations
- Università degli Studi di FirenzeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VCMX
CTG
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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))
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)
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)
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)
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)
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)
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)
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
KT
The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05458271
Brief Title
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft at Implant Site.
Official Title
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation at Implant Site. A Comparative, Multicentre Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation at Dental Implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VCMX
Arm Type
Experimental
Arm Description
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.
Arm Title
CTG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VCMX
Intervention Description
A flap will be raised and VCMX will be placed in order to increase the soft tissue volume
Intervention Type
Procedure
Intervention Name(s)
CTG
Intervention Description
A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume
Primary Outcome Measure Information:
Title
GT
Description
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
Title
GT
Description
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
Title
GT
Description
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
Title
GT
Description
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
Title
GT
Description
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
Title
GT
Description
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
Title
GT
Description
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
12 months after surgery
Secondary Outcome Measure Information:
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
PROMs
Description
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
Title
KT
Description
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
Title
KT
Description
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
Title
KT
Description
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
Title
KT
Description
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
Title
KT
Description
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
Title
KT
Description
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
Title
KT
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Barbato, Dr.
Phone
+393299457556
Email
luigi.barbato@unifi.it
Facility Information:
Facility Name
Università degli Studi di Firenze
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Barbato, Dr.
Phone
+393299457556
Email
luigi.barbato@unifi.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft at Implant Site.
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