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Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

Primary Purpose

Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Soft Tissue graft augmentation

Implant Placement

About this trial

This is an interventional treatment trial for Soft Tissue Atrophy focused on measuring soft tissue graft, acellular dermal graft, collagen matrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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%.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

SCTG group

CM group

PADM group

Arm Description

Implant placement and prosthetic rehabilitation of the missing tooth

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

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

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

Outcomes

Primary Outcome Measures

soft tissue volume gain

Optical scans superposition

Secondary Outcome Measures

soft tissue volume stability

Optical scans superposition

Plaque index (PI)

Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972)

Bleeding on probing (BI)

Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After a gentle probing if the gingiva bleeds will be positive.

Probing depth (PD)

in the implant area (implant and both tooth next to it). Distance from the gingival margin to the bottom of the gingival sulcus using periodontal probe (UNC 15). Measured in 6 points: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual.

Width of keratinized tissue (KT)

in the implant area (implant and both teeth nxt to it). Measured in the medial buccal point of the tooth/implant. Distance from mucogingival junction to the most apical portion of the crest of the marginal gingiva. The mucogingival junction will be identified by the roll technique, wherein the mucosa is rolled until the non-movable portion of the attached keratinized tissue is seen

Phenotype evaluation (PT)

the gingival biotype was categorized as thin or thick based on the transparency of a periodontal probe (CP15 UNC; Hu-Friedy, Chicago, IL, USA) through the soft tissues while probing the buccal sulcus of the contra-lateral tooth (17-19)

Patient reported outcome measures (PROMs)

patient pain/discomfort will be evaluated (a questionnaire will be provided to each patient after all the surgery procedures and it will be recollected the day of suture removal)

Pink Esthetic Score (PES)

will be registered to obtain information related to the papilla, the level of soft-tissue margin, the alveolar process, the color, contour and texture of the same soft tissue

Full Information

NCT ID

NCT04766255

First Posted

February 17, 2021

Last Updated

February 20, 2021

Sponsor

Universitat Internacional de Catalunya

1. Study Identification

Unique Protocol Identification Number

NCT04766255

Brief Title

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.

Official Title

Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2021 (Anticipated)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge

Keywords

soft tissue graft, acellular dermal graft, collagen matrix

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

controlled randomized prospective clinical study.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Implant placement and prosthetic rehabilitation of the missing tooth

Arm Title

SCTG group

Arm Type

Experimental

Arm Description

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

Arm Title

CM group

Arm Type

Experimental

Arm Description

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

Arm Title

PADM group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Soft Tissue graft augmentation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Implant Placement

Intervention Description

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.

Primary Outcome Measure Information:

Title

soft tissue volume gain

Description

Optical scans superposition

Time Frame

after 3 months

Secondary Outcome Measure Information:

Title

soft tissue volume stability

Description

Optical scans superposition

Time Frame

after 15 months

Title

Plaque index (PI)

Description

Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972)

Time Frame