Clinical trial NCT05744726: Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia
Official title: Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia: A Single-blind Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Extraction Socket Hemostasis
Post-Extraction Socket Pain Relief
Post-Extraction Socket Healing
Keywords: Platelet Rich Fibrin
Wound Healing
Tooth Extraction
Pain Severity
Bone wax
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
Collaborators: name: Jinnah Postgraduate Medical Centre
First posted: 2023-02-27
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 \[insert effects\].


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.

Primary outcomes:
measure: Pain Relief on VAS
timeFrame: 21 days
measure: Extraction socket healing
timeFrame: 21 days
Secondary outcomes:
measure: Hemostasis
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Centre
state: Sindh
Study officials:
References:
citation: Ruta DA, Bissias E, Ogston S, Ogden GR. Assessing health outcomes after extraction of third molars: the postoperative symptom severity (PoSSe) scale. Br J Oral Maxillofac Surg. 2000 Oct;38(5):480-7. doi: 10.1054/bjom.2000.0339.
citation: Landry RG, Turnbell RS, Howley T (1988) Effectiveness of benzydamine HCL in treatment of periodontal post-surgical patients. Res Clin Forums 10:105-118.
citation: Yelamali T, Saikrishna D. Role of platelet rich fibrin and platelet rich plasma in wound healing of extracted third molar sockets: a comparative study. J Maxillofac Oral Surg. 2015 Jun;14(2):410-6. doi: 10.1007/s12663-014-0638-4. Epub 2014 Jun 28.