NCT04383158

Alveolar Socket Healing With and Without PRGF

Characterisation of Wound Healing in the Dental Extraction Socket With and Without Plasma Rich in Growth Factors (PRGF). A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alveolar Bone Resorption
• Wound Heal

Interventions

Type	Name	Description
OTHER	PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)	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.

Timeline

• Start date: 2021-08-10
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2020-05-12
• Last updated: 2024-07-23

Locations

1 site across 1 country: United Kingdom