An interventional study of PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) in Alveolar Bone Resorption and Wound Heal, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
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.
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.
153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.
This study's enrollment of 15 is below the median of 22 across 133 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
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All of the following criteria must be fulfilled for inclusion:
Exclusion criteria
All patients to be enrolled who meet the inclusion / exclusion criteria will be asked if they have participated in any other interventional periodontal studies within the last 3 months. If the patient did participate in such studies, then enrolment will be postponed until after 3 months wash-out period has elapsed.
Immediately after dental extraction, the socket will be filled with Plasma Rich in Growth Factors (ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16))
Other: PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)
Dental extraction sockets to be left to heal spontaneously unassisted.
ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) is a system for obtaining plasma rich in growth factors (PRGF), which can be applied in the regeneration of bone and other connective tissues in oral surgery. PRGF is a completely autologous blood platelet concentrate that stimulates tissue regeneration due to enrichment with autologous growth factors, acting as a biological system.
Intra-oral geometric and thermographic changes of the alveolar ridge
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.
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Extra-oral geometric changes of the whole face at 1, 3, 7, 15, and 30 days after dental extraction
Changes expressed as percentages of extra-oral geometric volumes at selected areas of interest at 1, 3, 7, 15, and 30 days after dental extraction
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, and 30.
Extra-oral thermographic changes of the whole face at 1, 3, 7, 15, 30 and 90 days after dental extraction
Changes expressed as percentages of extra-oral thermographic changes at selected areas of interest at 1, 3, 7, 15, 30 and 90 days after dental extraction.
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Blood flowgraphy changes of intra-oral soft tissue of the dental extraction socket
Changes expressed as percentage of blood flowgraphy measured with Laser Speckle Contrast Imaging (LSCI) of intra-oral soft tissue of the dental extraction socket
Time frame: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.
Molecular (proteomic) changes of wound exudate of the dental extraction socket
Descriptive account of molecular (proteomic) changes of wound exudate of the dental extraction socket after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis
Time frame: From dental extraction and post-operative days 1, 3, 7, and 15.
Clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)
Qualitative clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)
Time frame: From dental extraction and post-operative days 1, 3, 7, and 15.
Post-operative pain assessed with a visual analogue scale (VAS)
Changes in the values of reported visual analogue scale (VAS) of 10 grades (value of 1= no pain, value of 10= maximum pain) to assess post-operative pain
Time frame: 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
Percentage of 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
Time frame: 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
Percentage of new bone formation assessed with histological analysis and X-ray microtomography (XMT) within bone core samples obtained after 3 months of healing at the dental implant placement procedure
Time frame: At 90 days of healing after dental extraction.
Feasibility of implant placement expressed as percentages (%) of implants placed with satisfactory primary stability
Percentage of implants placed with satisfactory primary stability in the optimal prosthetically driven 3-D position
Time frame: At 90 days of healing after dental extraction.
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
Percentage of implants that required further ridge augmentation procedures during implant placement for the management of residual dehiscence or fenestration defects
Time frame: 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
Percentage of implant survival and success according to success criteria of Buser et al (Buser et al 1990)
Time frame: At 12 months after implant loading
- 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
- Descriptive account of 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
Time frame: at suture removal after implant placement and at 6 months and 12 months after implant loading.
Papilla Fill Index, Pink Esthetic Score (PES) and White Esthetic Score (WES) at 6 months and 12 months after implant loading
PFI, PES and WES scores
Time frame: 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
Percentage of geometric changes of the peri-implant soft tissues
Time frame: at 6 months and 12 months after implant loading
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Queen Mary University of London