NCT05466006

Brief Summary

This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (\<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

July 8, 2022

Last Update Submit

November 27, 2023

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (5)

  • Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)

    Mean linear change in mm at the buccal aspect 1mm below the soft tissue margin

    12 months

  • Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)

    The distance between the buccal soft tissue margin and the base of the pocket

    12 months

  • Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)

    The distance between the crown margin and the mucosal margin

    12 months

  • Pain (VAS scale)(0-10 with higher values indicating worse outcomes)

    Subjective pain experienced by the patient expressed in a VAS scale

    12 months

  • Bleeding on probing (0 no bleeding, 1 presence of bleeding)

    Bleeding after probing within 15 seconds

    12 months

Study Arms (2)

Subepithelial Connective Tissue Graft (SCTG)

ACTIVE COMPARATOR

Soft tissue augmentation at peri-implant small buccal dehiscence with subepithelial connective tissue graft harvested from the patient's palate

Procedure: Soft tissue augmentation with subepithelial connective tissue graft (SCTG)

Volume Stable Collagen Matrix (VCMX)

EXPERIMENTAL

Soft tissue augmentation at peri-implant small buccal dehiscence with xenogenic volume stable collagen matrix

Procedure: Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)

Interventions

Soft tissue augmentation with subepithelial connective tissue graft (SCTG)PROCEDURE

After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), SCTG will be harvested from the palate and sutured to the flap. Simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.

Subepithelial Connective Tissue Graft (SCTG)
Soft tissue augmentation with xenogenic volume stable collagen matrix (VCXM)PROCEDURE

After the assessment of the vestibular bone dehiscence at implant site from the most apical extension of the trans-mucosal implant collar (≤3 mm evaluated in a vertical direction), VCMX will be sutured to the flap and simple interdental sutures will be performed in order to stabilize the flap in close contact with the healing screw.

Volume Stable Collagen Matrix (VCMX)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single tooth edentulous space
  • Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT
  • Completed non-surgical periodontal therapy (if needed)
  • FMPS and FMBS \< 20%

You may not qualify if:

  • Age \< 18 years old
  • Pregnancy or lactation
  • Heavy smokers (\> 10 cigarette/day)
  • Conditions or diseases contraindicating surgical interventions
  • Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement
  • Need for bone regeneration at the implant site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin

Turin, Italy

RECRUITING

Related Publications (1)

  • Ferrarotti F, Baima G, Mohammadi G, Carboncini C, Romano F, Aimetti M. Peri-Implant Soft Tissue Increase at Small Buccal Bone Dehiscences With Either Volume-Stable Collagen Matrix or Connective Tissue Graft: A Randomized Controlled Trial. Clin Oral Implants Res. 2025 Jul;36(7):846-858. doi: 10.1111/clr.14430. Epub 2025 Mar 19.

    PMID: 40105088DERIVED

Central Study Contacts

Mario Aimetti

CONTACT

00390116331546mario.aimetti@unito.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 20, 2022

Study Start

September 5, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

IT(1)