Tooth ExtractionNCT04452734
Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
A study testing Platelet Rich Plasma (PRP) and Surgical Extraction in people with Tooth Extraction, run by Foundation University Islamabad.
Trial summary
Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Platelet Rich Plasma (PRP) and Surgical Extraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 21 Jul 2015to 14 May 2016
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-45 iyears
- Either gender
- Patients requiring extraction of mandibular 3rd molars
- ASA grade1
- Nonsmokers \& non alcoholics
- Not allergic to any medicines
- No pain before the extraction procedure
- No trismus, i.e. normal mouth opening before the extraction procedure -
Who cannot join
- Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant females/Lactating mothers g) Presence of pericoronitis, periapical infection or any associated lesion.
- -
About this study
Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life.
PRP is an autologous concentrate of platelet in plasma and accelerate healing by production of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site.
Read the detailed description
Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period includes pain, swelling, trismus , along with disturbance in post extraction wound healing which may significantly affect patient's quality of life.
PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by production of various growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site. PRP speeds up healing by concentration of growth factors which can lessen the inflammation and decreases trismus and pain.
- Conditions
- Tooth Extraction
- Being tested
- Platelet Rich Plasma (PRP), Surgical Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (PRP)Procedure or surgery
PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures
Surgical ExtractionProcedure or surgery
Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Procedure: Surgical Extraction |
| Study Group | Experimental | Not described Receives: Procedure: Platelet Rich Plasma (PRP); Procedure: Surgical Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) used to quantify pain
Measured: 1 day
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) used to quantify pain
Measured: 3rd post op day
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) used to quantify pain
Measured: 7th post op day
Trismus
Trismus was quantified/measured using Vernier Calliper.
Measured: 1 day
Trismus
Trismus was quantified/measured using Vernier Calliper.
Measured: 3rd post op day
Trismus
Trismus was quantified/measured using Vernier Calliper.
Measured: 7th post op day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start21 Jul 2015
- Primary completion14 May 2016
- Study completion14 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maidah Hanif, BDS, FCPS, Principal investigator, Foundation University College of DentistryMuhammad Azhar Sheikh, BDS, MSc, FFD, Study chair, Foundation University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452734
- Sponsor's protocol ID
- FUI/CTR/2020/3
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogundipe OK, Ugboko VI, Owotade FJ. Can autologous platelet-rich plasma gel enhance healing after surgical extraction of mandibular third molars? J Oral Maxillofac Surg. 2011 Sep;69(9):2305-10. doi: 10.1016/j.joms.2011.02.014. Epub 2011 May 7.
PubMed 21550158Celio-Mariano R, de Melo WM, Carneiro-Avelino C. Comparative radiographic evaluation of alveolar bone healing associated with autologous platelet-rich plasma after impacted mandibular third molar surgery. J Oral Maxillofac Surg. 2012 Jan;70(1):19-24. doi: 10.1016/j.joms.2011.03.028. Epub 2011 Jul 20.
PubMed 21778014
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
- ClinicalTrials.gov ID
- NCT04452734
- Acronym / sponsor ID
- FUI/CTR/2020/3
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 14 May 2016 (actual)
- Study completion
- 14 May 2016 (actual)
- First posted
- 30 Jun 2020 (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.
Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life.
PRP is an autologous concentrate of platelet in plasma and accelerate healing by production of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site.
Detailed description
Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period includes pain, swelling, trismus , along with disturbance in post extraction wound healing which may significantly affect patient's quality of life.
PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by production of various growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site. PRP speeds up healing by concentration of growth factors which can lessen the inflammation and decreases trismus and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Surgical Extraction |
| Study Group | Experimental | Procedure: Platelet Rich Plasma (PRP), Procedure: Surgical Extraction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18-45 iyears
- Either gender
- Patients requiring extraction of mandibular 3rd molars
- ASA grade1
- Nonsmokers \& non alcoholics
Key exclusion criteria (2 listed)
- Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant females/Lactating mothers g) Presence of pericoronitis, periapical infection or any associated lesion.
- -
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 |
|---|---|---|
| Platelet Rich Plasma (PRP)PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures | Procedure or surgery | Study Group |
| Surgical ExtractionSurgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement. | Procedure or surgery | Control Group, Study Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 1 day
Visual Analogue Scale (VAS) used to quantify pain
Visual Analogue Scale (VAS)
Time frame: 3rd post op day
Visual Analogue Scale (VAS) used to quantify pain
Visual Analogue Scale (VAS)
Time frame: 7th post op day
Visual Analogue Scale (VAS) used to quantify pain
Trismus
Time frame: 1 day
Trismus was quantified/measured using Vernier Calliper.
Trismus
Time frame: 3rd post op day
Trismus was quantified/measured using Vernier Calliper.
Trismus
Time frame: 7th post op day
Trismus was quantified/measured using Vernier Calliper.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 21550158Ogundipe OK, Ugboko VI, Owotade FJ. Can autologous platelet-rich plasma gel enhance healing after surgical extraction of mandibular third molars? J Oral Maxillofac Surg. 2011 Sep;69(9):2305-10. doi: 10.1016/j.joms.2011.02.014. Epub 2011 May 7.
- Background: PubMed 21778014Celio-Mariano R, de Melo WM, Carneiro-Avelino C. Comparative radiographic evaluation of alveolar bone healing associated with autologous platelet-rich plasma after impacted mandibular third molar surgery. J Oral Maxillofac Surg. 2012 Jan;70(1):19-24. doi: 10.1016/j.joms.2011.03.028. Epub 2011 Jul 20.
- Individual participant dataSharing planned: No
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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.
Maidah Hanif, BDS, FCPS principal investigator
Foundation University College of Dentistry
Muhammad Azhar Sheikh, BDS, MSc, FFD study chair
Foundation University College of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma (PRP) and Surgical Extraction in people with Tooth Extraction, run by Foundation University Islamabad.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 1 day). The study lists 6 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 NCT04452734, which also lists 2 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 30 Jun 2020.