Post-Extraction Socket HemostasisNCT05744726
Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia
A study testing A-PRF and Bone-wax in people with Post-Extraction Socket Hemostasis and Post-Extraction Socket Pain Relief, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Extraction Socket Hemostasis, Post-Extraction Socket Pain Relief, Post-Extraction Socket Healing
- What is being tested?
- A-PRF and Bone-wax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Postgraduate Medical Centre
Karachi, Sindh, 75510
Rehan Ahmad, BDS, +92 343 8850508, rehan3489@gmail.com
Jehan Alam, FCPS, +92 300 2811979, drjanfcps@gmail.com
About this study
Official title: Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia: A Single-blind Randomised Control Trial
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].
- Conditions
- Post-Extraction Socket Hemostasis, Post-Extraction Socket Pain Relief, Post-Extraction Socket Healing
- Being tested
- A-PRF, Bone-wax
- Keywords
- Platelet Rich Fibrin, Wound Healing, Tooth Extraction, Pain Severity, Bone wax
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRFBiological
0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket.
Bone-waxCombination product
Also called combination of beeswax and other products
0.5 to 1g of Bone-wax for each dental socket
| Study group | Role | What they receive |
|---|---|---|
| A-PRF | Experimental | Advance Platelet-Rich Fibrin Receives: Biological: A-PRF |
| Bone-wax | Active comparator | Not described Receives: Combination Product: Bone-wax |
| Conventional Dental Extraction protocol | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 21 days
Secondary outcomes (1)
Hemostasis
The post-operative bleeding will be evaluated 30 minutes after the placement of the last suture as:
- No bleeding
- Mild Bleeding: bleeding that stopped spontaneously or with minimal local compression.
- Severe Bleeding: bleeding that did not stop with the previous measures and that required local adrenaline or continuous local compression using gauze pack soaked in the corresponding antifibrinolytic agent until the bleeding stops
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Extraction Socket HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Responsible party
- Principal investigator, Rehan Ahmad, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744726
- Sponsor's protocol ID
- F.2-81/2022-GENL/338/JPMC
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per institutional data privacy policy we are bound of not sharing patient data with other researchers
Publications
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.
PubMed 11010778Landry RG, Turnbell RS, Howley T (1988) Effectiveness of benzydamine HCL in treatment of periodontal post-surgical patients. Res Clin Forums 10:105-118.
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.
PubMed 26028867
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia: A Single-blind Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05744726
- Acronym / sponsor ID
- F.2-81/2022-GENL/338/JPMC
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-PRF | Experimental | Biological: A-PRFAdvance Platelet-Rich Fibrin |
| Bone-wax | Active comparator | Combination Product: Bone-wax |
| Conventional Dental Extraction protocol | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-PRF0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket. | Biological | A-PRF |
| Bone-waxAlso: combination of beeswax and other products0.5 to 1g of Bone-wax for each dental socket | Combination product | Bone-wax |
Primary outcome
Pain Relief on VAS
Time frame: 21 days
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).
Extraction socket healing
Time frame: 21 days
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.
1 secondary outcome
Hemostasis
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 11010778Ruta 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.
- BackgroundLandry RG, Turnbell RS, Howley T (1988) Effectiveness of benzydamine HCL in treatment of periodontal post-surgical patients. Res Clin Forums 10:105-118.
- Background: PubMed 26028867Yelamali 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.
- Individual participant dataSharing planned: No. As per institutional data privacy policy we are bound of not sharing patient data with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-PRF and Bone-wax in people with Post-Extraction Socket Hemostasis and Post-Extraction Socket Pain Relief, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief on VAS (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744726, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.