TrismusNCT03690167
Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
A study testing Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) in people with Trismus and Edema, run by Dr. Damla Torul at 1 site in Turkey (Türkiye).
Trial summary
The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2018to 20 Mar 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification
- Patients between the ages of 18-30,
- Non-smokers,
- Patients with ASA I status
Who cannot join
- Who does not want to be volunteer for the study,
- Do not comply with post-operative recommendations,
- Operation lasting more than 30 minutes,
- During pregnancy or lactation,
- Have a chronic systemic disorder that may affect healing.
- Unable to cooperate,
- Post-operative infection,
- Patients with pericoronitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of the Effects of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
Read the detailed description
In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.
- Conditions
- Trismus, Edema, Pain, Post-Op Complication
- Being tested
- Concentrated Growth Factor (CGF), Advanced Platelet Rich Fibrin (A-PRF), Control
- Medical subject headings
- Trismus, Edema, Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth Factor (CGF)Other
CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)
Advanced Platelet Rich Fibrin (A-PRF)Other
A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF)
ControlOther
Nothing applied after extraction
| Study group | Role | What they receive |
|---|---|---|
| Concentrated Growth Factor (CGF) | Active comparator | Participants with impacted lower third molar Receives: Other: Concentrated Growth Factor (CGF) |
| Advanced Platelet Rich Fibrin (A-PRF) | Active comparator | Participants with impacted lower third molar Receives: Other: Advanced Platelet Rich Fibrin (A-PRF) |
| Control | Sham comparator | Participants with impacted lower third molar Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema-amount change of swelling
In order to evaluate the amount change of swelling after the operation, horizontal and vertical measurements will be made from 5 reference points including tragus, lip corner, soft tissue pogonion, lateral cantus of the eye and gonion. The first measurement between the tragus-lip corner, the second measurement will be obtained by measuring the horizontal distance between the tragus-soft tissue pogonion. The third measurement will be determined by the measurement of the vertical distance between the outer corner of the eye and the gonion. to determine the change in the swelling measurements performed before surgery and at 2nd-7th days after surgery.
Measured: Baseline, 2nd and 7th days
Secondary outcomes (3)
Trismus- degree of change (limitation) in maximum mouth opening
The maximum mouth opening will be determined as the distance between the right lower and upper right central.
Measured: Baseline, 2nd and 7th days
Post operative Pain: visual analog (VAS) scale
For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10).
0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.
Measured: 6th and 24th hours, 2nd and 7th days
Post-operative symptom severity (PoSSe) scale
The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, andfor each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.
Measured: Post operative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start12 Jul 2018
- Primary completion1 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies 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
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Damla Torul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Damla Torul, Ordu University
- Investigators
- Damla Torul, PhD, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690167
- Sponsor's protocol ID
- 2018/163
- Status last verified
- Aug 2019
- First submitted
- 26 Sep 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can share with other researchers on demand
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Effects of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
- ClinicalTrials.gov ID
- NCT03690167
- Acronym / sponsor ID
- 2018/163
- Conditions
- Trismus, Edema, Pain, Post-Op Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dr. Damla TorulUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 1 Oct 2018 (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 objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
Detailed description
In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concentrated Growth Factor (CGF) | Active comparator | Other: Concentrated Growth Factor (CGF)Participants with impacted lower third molar |
| Advanced Platelet Rich Fibrin (A-PRF) | Active comparator | Other: Advanced Platelet Rich Fibrin (A-PRF)Participants with impacted lower third molar |
| Control | Sham comparator | Other: ControlParticipants with impacted lower third molar |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification
- Patients between the ages of 18-30,
- Non-smokers,
- Patients with ASA I status
Key exclusion criteria (8 listed)
- Who does not want to be volunteer for the study,
- Do not comply with post-operative recommendations,
- Operation lasting more than 30 minutes,
- During pregnancy or lactation,
- Have a chronic systemic disorder that may affect healing.
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 |
|---|---|---|
| Concentrated Growth Factor (CGF)CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF) | Other | Concentrated Growth Factor (CGF) |
| Advanced Platelet Rich Fibrin (A-PRF)A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF) | Other | Advanced Platelet Rich Fibrin (A-PRF) |
| ControlNothing applied after extraction | Other | Control |
Primary outcome
Edema-amount change of swelling
Time frame: Baseline, 2nd and 7th days
In order to evaluate the amount change of swelling after the operation, horizontal and vertical measurements will be made from 5 reference points including tragus, lip corner, soft tissue pogonion, lateral cantus of the eye and gonion. The first measurement between the tragus-lip corner, the second measurement will be obtained by measuring the horizontal distance between the tragus-soft tissue pogonion. The third measurement will be determined by the measurement of the vertical distance between the outer corner of the eye and the gonion. to determine the change in the swelling measurements performed before surgery and at 2nd-7th days after surgery.
3 secondary outcomes
Trismus- degree of change (limitation) in maximum mouth opening
Time frame: Baseline, 2nd and 7th days
Post operative Pain: visual analog (VAS) scale
Time frame: 6th and 24th hours, 2nd and 7th days
Post-operative symptom severity (PoSSe) scale
Time frame: Post operative 7th day
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 28 Aug 2019.
- Individual participant dataSharing planned: No. IPD can share with other researchers on demand
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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.
Damla Torul, PhD study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) in people with Trismus and Edema, run by Dr. Damla Torul at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 28 Aug 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Edema-amount change of swelling (time frame: Baseline, 2nd and 7th days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.