NCT05744726

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 \[insert effects\].

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 12, 2023

Last Update Submit

February 15, 2023

Conditions

Post-Extraction Socket HemostasisPost-Extraction Socket Pain ReliefPost-Extraction Socket Healing

Keywords

Platelet Rich FibrinWound HealingTooth ExtractionPain SeverityBone wax

Outcome Measures

Primary Outcomes (2)

  • Pain Relief on VAS

    Patients receiving any of the intervention will be evaluated at just before, 3rd, 7th and 21st day of dental extraction on Visual Analogue Scale (VAS).

    21 days

  • Extraction socket healing

    Patients receiving any of the intervention will be evaluated at 3rd, 7th and 21st day of dental extraction on Healing index by Landry et al.

    21 days

Secondary Outcomes (1)

  • Hemostasis

    30 minutes

Study Arms (3)

A-PRF

EXPERIMENTAL

Advance Platelet-Rich Fibrin

Biological: A-PRF

Bone-wax

ACTIVE COMPARATOR
Combination Product: Bone-wax

Conventional Dental Extraction protocol

NO INTERVENTION

Control Group

Interventions

A-PRFBIOLOGICAL

0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket.

A-PRF
Bone-waxCOMBINATION_PRODUCT

0.5 to 1g of Bone-wax for each dental socket

Also known as: combination of beeswax and other products
Bone-wax

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11010778BACKGROUND

  • Landry RG, Turnbell RS, Howley T (1988) Effectiveness of benzydamine HCL in treatment of periodontal post-surgical patients. Res Clin Forums 10:105-118.

    BACKGROUND

  • 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.

    PMID: 26028867BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

bone wax

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator/Lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 27, 2023

Study Start

January 1, 2023

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

As per institutional data privacy policy we are bound of not sharing patient data with other researchers

Locations

PA(1)