Alveolar Socket Healing With and Without PRGF
Alveolar Socket Healing With and Without PRGF
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.
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, osteoporosis) or transmittable diseases (e.g. AIDS).

 -  History of alcohol or drug abuse.

 -  Smokers.

 -  Self-reported pregnancy or lactation (this criterion is due to oral tissue changes
 related to pregnancy and nursing which can affect interpretation of study results).

 -  Other severe acute or chronic medical or psychiatric condition or laboratory
 abnormality that may increase the risk associated with trial participation or
 investigational product administration or may interfere with the interpretation of
 trial results and, in the judgement of the investigator, would make the subject
 inappropriate for entry into this trial.

 -  Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar
 compensation which could interfere with ridge preservation dimensions and
 measurements.

 -  Lack of adjacent sound restored or unrestored teeth.

 -  Any male participants with facial hair (such as moustache, beard or any other
 variations of facial hair styles) and must keep their face shaven until after the
 placement of the dental implant (Visit 10).

 -  Any individuals using Botox or fillers in the face region.

 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.