NCT04766255

Brief Summary

The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
8mo left

Started May 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress89%
May 2021Dec 2026

First Submitted

Initial submission to the registry

February 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

4.7 years

First QC Date

February 17, 2021

Last Update Submit

December 5, 2024

Conditions

Soft Tissue AtrophyMucogingival Deformity on Edentulous RidgeEdentulous Alveolar Ridge

Keywords

soft tissue graftacellular dermal graftcollagen matrix

Outcome Measures

Primary Outcomes (1)

  • soft tissue volume gain

    Optical scans superposition

    after 3 months

Secondary Outcomes (8)

  • soft tissue volume stability

    after 15 months

  • Plaque index (PI)

    at baseline, after 12 weeks and after 15 months.

  • Bleeding on probing (BI)

    at baseline, after 12 weeks and after 15 months.

  • Probing depth (PD)

    at baseline, after 12 weeks and after 15 months.

  • Width of keratinized tissue (KT)

    at baseline, after 12 weeks and after 15 months.

  • +3 more secondary outcomes

Study Arms (4)

Control Group

ACTIVE COMPARATOR

Implant placement and prosthetic rehabilitation of the missing tooth

Procedure: Implant Placement

SCTG group

EXPERIMENTAL

Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.

Procedure: Soft Tissue graft augmentationProcedure: Implant Placement

CM group

EXPERIMENTAL

Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.

Procedure: Soft Tissue graft augmentationProcedure: Implant Placement

PADM group

EXPERIMENTAL

Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.

Procedure: Soft Tissue graft augmentationProcedure: Implant Placement

Interventions

Soft Tissue graft augmentationPROCEDURE

Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture

CM groupPADM groupSCTG group
Implant PlacementPROCEDURE

A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.

CM groupControl GroupPADM groupSCTG group

Eligibility Criteria

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

You may qualify if:

  • Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
  • The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
  • The implant must be located between 2 fixed reference points (i.e. clinical crowns).
  • Anterior and premolar teeth (from premolar to premolar).
  • Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
  • Palate must have ≥2mm of thickness at premolar area.
  • Full mouth plaque and bleeding score \<20%.

You may not qualify if:

  • Pregnant or lactation.
  • Active periodontal disease.
  • Previous soft tissue augmentation in the area.
  • Need of guided bone regeneration (GBR) during or after the placement of the implant.
  • Heavy smokers (\> 10 cigarettes per day).
  • Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
  • Allergy to non-steroidal anti-inflammatory drugs.
  • Patients taking medications that cause gingival enlargement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Study Officials

  • Andres Pascual La Rocca, DDS

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres Pascual La Rocca, DDS

CONTACT

0034627725044pascuallarocca@hotmail.com

Cristina Valles Vega, DDS

CONTACT

0034627725044cristinavallveg@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: controlled randomized prospective clinical study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Periodontics program director

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 23, 2021

Study Start

May 1, 2021

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)