Alveolar Socket Healing With and Without PRGF (NCT04383158) | Clinical Trial Compass
CompletedNot Applicable
Alveolar Socket Healing With and Without PRGF
United Kingdom15 participantsStarted 2021-08-10
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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Inclusion Criteria
All of the following criteria must be fulfilled for inclusion:
* Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥25 years old.
* Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for 2/3rd of the root nor associated with acute periapical pathology.
* Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of \>50% buccal bone loss, the participant will be withdrawn.
* Patient in good general health as documented by self-assessment.
* Full mouth bleeding and plaque scores (FMBS \<10% and FMPS \<20%) recorded within the previous 8 weeks.
Exclusion criteria
* Uncontrolled or untreated periodontal disease.
* History of local (head and neck) radiation therapy.
* Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
* Severe bruxing or clenching habits.
* Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
* Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteopo…
What they're measuring
1
Intra-oral geometric and thermographic changes of the alveolar ridge
Timeframe: From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.