Soft Tissue Changes Around Dental Implants

NCT04265768 | Completed

• 1 other identifier: IRAS 268553
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.

Conditions

Tooth Loss; Dental Diseases; Wound Heal

Keywords

soft tissue regeneration; soft tissue graft; dental implant; imaging

Outcome Measures

Primary Outcomes (4)

• 3D intra-oral volume changes in mucosal soft tissue following augmentation

  Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.

  Immediately after implant placement.

• 3D intra-oral volume changes in mucosal soft tissue following augmentation

  Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.

  7, 14 and 30 Days post implant placement

• 3D intra-oral volume changes in mucosal soft tissue following augmentation

  Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.

  12 weeks and 16 weeks post- implant loading.

• 3D intra-oral volume changes in mucosal soft tissue following augmentation

  Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.

  12 month post- implant loading.

Secondary Outcomes (10)

• Changes in gingival thickness

  implant placement to 12 weeks after implant placement

• 3D extra-oral volumetric changes

  baseline, immediately after implant placement, 7, 14 and 30 days after implant placement

• 2D-3D intra-oral thermal changes

  baseline to 1, 3, 7, 14 and 30 days after implant placement

• changes in vascularisation

  before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30

• soft tissue aesthetics

  At implant loading and at 12 months after loading.

Study Arms (3)

No Soft tissue augmentation surgery

PLACEBO COMPARATOR

No soft tissue augmentation concomitant to implant placement. Negative control group.

Procedure: No soft tissue augmentation

Soft tissue augmentation surgery with Fibro-Gide

EXPERIMENTAL

Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland). Test group.

Procedure: Soft tissue augmentation surgery with Fibro-Gide

Soft tissue augmentation surgery with patient's CTG

ACTIVE COMPARATOR

Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area. Positive control group.

Procedure: Soft tissue augmentation surgery with CTG

Interventions

Soft tissue augmentation surgery with CTG PROCEDURE

An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm). The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.

Soft tissue augmentation surgery with patient's CTG

Soft tissue augmentation surgery with Fibro-Gide PROCEDURE

Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.

Soft tissue augmentation surgery with Fibro-Gide

No soft tissue augmentation PROCEDURE

During implant placement surgery, no soft tissue augmentation will be performed

No Soft tissue augmentation surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 80 years.
• Good medical and psychological health.
• Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
• Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
• Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
• A residual alveolar height \>8 mm, enough inter-arch space for a crown and a minimum distance of 6 mm from the adjacent teeth.
• The width and height will be confirmed after x-ray examination in Visit 1 (or extra visit). Cases of small apical fenestration (≤ 25% of implant length) after implant placement will not be excluded, but will be treated according to the GBR principle (collagen membrane associated with a deproteinized bovine bone graft) to re-establish the bone contour and without over contouring.
• At least 8 weeks of post-extraction socket healing had occurred in the edentulous site.
• Willingness to sign the informed consent form.

You may not qualify if:

• Self-reported pregnancy and lactation.
• Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
• Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
• HIV or viral hepatitis.
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
• Self-reported alcoholism or chronic drug abuse.
• Heavy smokers (\>10/cigarettes per day).
• Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could be obtained or simple instructions could be followed.
• Full-mouth bleeding (BOP) and plaque (PI) scores \>30% or sites with periodontal pocket depth \>5 mm at the completion of the pre-treatment phase.
• Very thin or very thick biotypes that according to the clinician's judgement would either risk to have complications or would not benefit from receiving a graft.
• \<2 mm KT buccally (from the mucogingival junction to the coronal aspect of the crestal soft tissue).

Sponsors & Collaborators

• Queen Mary University of London: lead
• Geistlich Pharma AG: collaborator

Study Sites (2)

Barts and The London Dental Hospital

London, E1 2AD, United Kingdom

Location

Centre for Oral Clinical Research (COCR)

London, E1 2AD, United Kingdom

Location

MeSH Terms

Conditions

Tooth Loss; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Tooth Diseases

Study Officials

• Nikos Donos, PhD

  Barts & The London School of Medicine & Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be un-blinded. Conversely, outcome examiners will be blinded to treatment allocation throughout the whole study duration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will includes 3 groups randomised in parallel.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 12, 2020
• Study Start: June 21, 2021
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)