Clinical trial

Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia: A Single-blind Randomised Control Trial

Name
F.2-81/2022-GENL/338/JPMC
Description
The goal of this clinical trial is to compare the pain relief and healing effect of A-PRF and Bone-wax in patients having mandibular tooth-extractions. The main question\[s\] it aims to answer are: In the perspective of improvement in pain and healing; * Does A-PRF performs better than control group? * Does Bone-wax performs better than control group? * Healing index and Pain scale score Comparison of A-PRF and Bone-wax; if one is better than the other? Participants will be asked to give resoponse to a post-operative symptom severiety (PoSSe) scale. An investigator will score the patient's extraction for hemostasis and on healing index \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-06-30
Trial end
2023-09-30
Status
Recruiting
Treatment
A-PRF
0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket.
Arms:
A-PRF
Bone-wax
0.5 to 1g of Bone-wax for each dental socket
Arms:
Bone-wax
Other names:
combination of beeswax and other products
Size
129
Primary endpoint
Pain Relief on VAS
21 days
Extraction socket healing
21 days
Eligibility criteria
Inclusion Criteria: * All patients who need extraction of mandibular posterior teeth * Overall, systemically healthy individuals (Established based on history, i.e., patients who do not take medicine for any systemic condition). * INR within normal range. Exclusion Criteria: * Patients with a diagnosed systemic condition. * Patients who are immunocompromised. * Patients who are unwilling to participate or withdraw from the study. * Patients who fail to report on the seventh and twenty-first post-extraction day. * Patients with physical or mental impairments who need assistance in taking their medications.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 129, 'type': 'ESTIMATED'}}
Updated at
2023-02-27

1 organization

2 products

3 indications

Product
A-PRF
Indication
Dry Socket
Indication
Alveolitis
Product
Bone-wax