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NCT Number: NCT05458271

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Edentulous Alveolar Ridge Atrophy Soft Tissue Augmentation at Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi di Firenze

Florence, FI, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCMX

Device

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

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

Primary outcomes

  1. GT

    Time frame: Immediately After Surgery

    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. GT

    Time frame: 1 week After surgery

    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. GT

    Time frame: 2 weeks After surgery

    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. GT

    Time frame: 4 weeks After surgery

    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.

  5. GT

    Time frame: 3 months After surgery

    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. GT

    Time frame: 6 months after surgery

    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.

  7. GT

    Time frame: 12 months after surgery

    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 outcomes

  1. PROMs

    Time frame: Immediately After Surgery

    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))

  2. PROMs

    Time frame: 1 week After surgery

    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)

  3. PROMs

    Time frame: 2 weeks After surgery

    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)

  4. PROMs

    Time frame: 4 weeks After surgery

    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)

  5. PROMs

    Time frame: 3 months After surgery

    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)

  6. PROMs

    Time frame: 6 months after surgery

    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)

  7. PROMs

    Time frame: 12 months after surgery

    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)

  8. KT

    Time frame: At Baseline

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

  9. KT

    Time frame: 1 week After surgery

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

  10. KT

    Time frame: 2 weeks After surgery

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

  11. KT

    Time frame: 4 weeks After surgery

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

  12. KT

    Time frame: 3 months After surgery

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

  13. KT

    Time frame: 6 months after surgery

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

  14. KT

    Time frame: 12 months after surgery

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

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation At Implant Site. a Comparative, Multicentre Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jul 14, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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