Status:
COMPLETED
Alveolar Socket Healing With and Without PRGF
Lead Sponsor:
Queen Mary University of London
Conditions:
Alveolar Bone Resorption
Wound Heal
Eligibility:
All Genders
25+ years
Phase:
NA
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...
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 wit...
Eligibility Criteria
Inclusion
- 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50% buccal bone loss, the participant will be withdrawn.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.
Exclusion
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04383158
Start Date
August 10 2021
End Date
April 16 2024
Last Update
July 23 2024
Active Locations (1)
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1
Centre for Oral Clinical Research
London, United Kingdom, E1 2AD