Characterisation of Wound Healing in the Dental Extraction Socket With and Without Plasma Rich in Growth Factors (PRGF). A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alveolar Bone Resorption
- Sponsor
- Queen Mary University of London
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Intra-oral geometric and thermographic changes of the alveolar ridge
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A single-centre randomised controlled pilot study involving 12-24 healthy adult patients for investigating dental extraction socket healing with and without plasma rich in growth factors (PRGF) taking place during early days of healing (days 1, 3, 7, 15, 30) and relating the healing to clinical and histological outcomes after 90 days of healing. Healing will be investigated by means of various non-invasive imaging technologies (e.g. laser scanners, thermal cameras, laser cameras) in addition to conventional technologies (e.g. bone core biopsy, 3D xray images). At 90 days of healing, dental implants will be placed in the healed sockets and implants will be restored and followed up until 12 months after connecting the prosthesis to the implant (e.g. implant crown). Dental implant outcomes (e.g. survival, success) will also be evaluated.
Detailed Description
Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study. Objectives: the study aims to characterise wound healing events in the dental extraction socket with and without plasma rich in growth factors (PRGF) taking place during early days of healing after a dental extraction and their relation to clinical and histological outcomes after 90 days of healing. The early healing events of the post-extraction socket will be characterized in terms of volumetric changes in relation to intra-oral thermographic changes, blood flowgraphy, molecular (proteomic) changes, as well as extra-oral integrated geometric thermographic changes in tandem with clinical measures of soft tissue healing, post-operative pain assessment. The early healing events will be analysed in relation to volumetric, clinical and histomorphometric changes of new bone formation after 90 days of healing during dental implant treatment. Dental Implant outcomes will be evaluated up to 12 months after loading. Duration: Overall, we anticipate that the study will last approximately 28 months. We estimate a 3-month study set-up period, followed by a recruitment period of 6 months. Each participant will attend 14 visits over approximately 18-19 months. The first 9 visits involve a dental extraction and follow-up until 90 days after extraction to obtain a bone core biopsy and dental implant placement. Visits 10 to 14 will be for restoring the dental implant and evaluating dental implant treatment outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Intra-oral geometric and thermographic changes of the alveolar ridge
Time Frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Changes expressed as percentages of intra-oral geometric volumes and temperatures within a defined region of interest (ROI) at 1, 3, 7, 15, 30 and 90 days after dental extraction in unassisted socket healing and PRGF-assisted healing. The ROIs will include the buccal, crestal, and palatal surfaces of the extraction socket defined proximally between two vertical planes parallel to the tooth axis in the middle of the mesial and distal papilla, and defined superiorly by a horizontal plane at the level of the mucogingival line.dental extraction in unassisted socket healing and PRGF-assisted healing.
Secondary Outcomes
- Molecular (proteomic) changes of wound exudate of the dental extraction socket(From dental extraction and post-operative days 1, 3, 7, and 15.)
- Need for further augmentation expressed as a percentage (%) of implants that required further ridge augmentation procedures during implant placement for the management of residual dehiscence or fenestration defects(At 90 days of healing after dental extraction.)
- Extra-oral thermographic changes of the whole face at 1, 3, 7, 15, 30 and 90 days after dental extraction(From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.)
- Clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)(From dental extraction and post-operative days 1, 3, 7, and 15.)
- Feasibility of implant placement expressed as percentages (%) of implants placed with satisfactory primary stability(At 90 days of healing after dental extraction.)
- Implant survival and success according to success criteria of Buser et al (Buser et al., 1990) assessed at 12 months after implant loading(At 12 months after implant loading)
- Post-operative pain assessed with a visual analogue scale (VAS)(From dental extraction and post-operative days 1, 3, 7, and 15.)
- Geometric changes of 3-D radiographic bone (CBCT) and 3-D optically scanned soft tissue at suture removal (7 days) and at 90 days of healing(At suture removal at 7 days after dental extraction and at 90 days of healing.)
- Histomorphometric new bone formation assessed with histology and X-ray microtomography (XMT), to calculate the percentages of new bone within bone core samples obtained after 3 months of healing at the dental implant placement procedure(At 90 days of healing after dental extraction.)
- Papilla Fill Index, Pink Esthetic Score (PES) and White Esthetic Score (WES) at 6 months and 12 months after implant loading(at 6 months and 12 months after implant loading)
- - Intra-oral geometric changes of the peri-implant soft tissue at 6 months and 12 months after implant loading(at 6 months and 12 months after implant loading)
- Extra-oral geometric changes of the whole face at 1, 3, 7, 15, and 30 days after dental extraction(From dental extraction and post-operative days 1, 3, 7, 15, and 30.)
- Blood flowgraphy changes of intra-oral soft tissue of the dental extraction socket(From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.)
- - Molecular (proteomic) changes of the peri-implant crevicular fluid at suture removal after implant placement and at 6 months and 12 months after implant loading(at suture removal after implant placement and at 6 months and 12 months after implant loading.)