NCT04265768

Soft Tissue Changes Around Dental Implants

Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing. An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way. This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts. Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.

Conditions

• Tooth Loss
• Dental Diseases
• Wound Heal

Interventions

Type	Name	Description
PROCEDURE	Soft tissue augmentation surgery with CTG	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.
PROCEDURE	Soft tissue augmentation surgery with Fibro-Gide	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.
PROCEDURE	No soft tissue augmentation	During implant placement surgery, no soft tissue augmentation will be performed

Timeline

• Start date: 2021-06-21
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2020-02-12
• Last updated: 2025-06-08

Locations

2 sites across 1 country: United Kingdom