Impacted Third Molar ToothNCT05944939
Assessment of Bone Density in Impacted Mandibular Third Molar
A study testing Surgical extraction of impacted third molar in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated… Read more about this study
- Who is it for?
- Ages 17 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Surgical extraction of impacted third molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesPakistan
- Study dates
- 4 May 2022to 6 Dec 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 17 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both genders
- Age above 17 years
- Impacted mandibular third molar
Who cannot join
- Teeth require closed extraction
- Significant medical history ( e.g. uncontrolled diabetes mellitus )
- Patients with history of radiotherapy and chemotherapy
- Bleeding disorders
- Any pathology like tumor and cyst 6. Developmental disorder 7. Previously operated any surgery of jaw 8. cigarette smokers 9. Maxillary third molar
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Dow Dental college Dow university of health sciences
Karachi, Sindh
Dow university of health sciences
Karachi, Sindh
About this study
Official title: "Post" Operative Assessment of Socket Healing With Placement of Concentrated Growth Factor in Impacted Mandibular Third Molar Socket
Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor.
Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively.
Read the detailed description
Total number of patients who will fulfill the inclusion criteria of the study will be included in the study from oral and maxillofacial surgery OPD of Dow University of health sciences dow dental college campus. Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor.
CONCENTRATED GROWTH FACTOR PREPARATION:
Concentrated growth factor is prepared by using patients own venous blood 10ml drawn from patients radial forearm which placed in without anticoagulant solutions in a sterile vacuette tubes. Centrifuged 30 sec acceleration, 2 mint -2700rmp, 4mint 2400rmp, 4 mints -2700rmp,3 mints -3000rmp, 30 sec deceleration and stop.
Concentrated growth factor contain rich growth factor taken from tube with help of tweezer with cutting two phases with scissors where the center and bottom layers connected. When concentrated growth factor is separated a quantity of growth factors is present at interface between concentrated growth factor and erythrocyte layer. concentrated growth factor glue is mould and squeezed the liquid element, to obtain a concentrated growth factor membrane and that membrane will be stored in normal saline for future.
In second case group. After open extraction of impacted mandibular third molar fresh socket closure will be performed with silk 3.0. Same Postoperative instruction and medication will be given to all patients. Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively. Comparision between mesioangular with mesioangular, distoangular with distoangular, horizontal with horizontal , vertical with vertical.(11)The mean gray level histogram values of the cone beam computed tomography at extraction socket will be obtained through digora software , gray scale is a digital photograpy , computer generated imagery and colorimetry . For each defect a regions of intrest can be created for the defect region and one the surrounding bone using the freehand selection tool, the minimum safety distance from one pixel to any cortical structure has to be ensured,after creating region of intrest the analysis is performed and result is transferred directly to statical analysis sheet,(Geiger, Blem et al. 2016) The difference in mean grey level values at study and control sites were tabulated and compared bone density. The purpose of using mandibular third molar because third molar is most commonly impacted teeth and routinly extracted with number of complications being reported and overcome these complication we are using CGF in third molar socket
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Surgical extraction of impacted third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extraction of impacted third molarProcedure or surgery
After surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | After third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group Receives: Procedure: Surgical extraction of impacted third molar |
| Control group | Experimental | After extraction closure with silk 3.0 compare bone density with cases Receives: Procedure: Surgical extraction of impacted third molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months
Cases compare with control with help of cone beam computerized tomography
Measured: 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start4 May 2022
- Primary completion6 Jun 2022
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D O W, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944939
- Sponsor's protocol ID
- Dow Dental
- Status last verified
- Oct 2022
- First submitted
- 30 May 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Randmised control trial
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Post" Operative Assessment of Socket Healing With Placement of Concentrated Growth Factor in Impacted Mandibular Third Molar Socket
- ClinicalTrials.gov ID
- NCT05944939
- Acronym / sponsor ID
- Dow Dental
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 14 Jul 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.
Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor.
Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively.
Detailed description
Total number of patients who will fulfill the inclusion criteria of the study will be included in the study from oral and maxillofacial surgery OPD of Dow University of health sciences dow dental college campus. Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor.
CONCENTRATED GROWTH FACTOR PREPARATION:
Concentrated growth factor is prepared by using patients own venous blood 10ml drawn from patients radial forearm which placed in without anticoagulant solutions in a sterile vacuette tubes. Centrifuged 30 sec acceleration, 2 mint -2700rmp, 4mint 2400rmp, 4 mints -2700rmp,3 mints -3000rmp, 30 sec deceleration and stop.
Concentrated growth factor contain rich growth factor taken from tube with help of tweezer with cutting two phases with scissors where the center and bottom layers connected. When concentrated growth factor is separated a quantity of growth factors is present at interface between concentrated growth factor and erythrocyte layer. concentrated growth factor glue is mould and squeezed the liquid element, to obtain a concentrated growth factor membrane and that membrane will be stored in normal saline for future.
In second case group. After open extraction of impacted mandibular third molar fresh socket closure will be performed with silk 3.0. Same Postoperative instruction and medication will be given to all patients. Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively. Comparision between mesioangular with mesioangular, distoangular with distoangular, horizontal with horizontal , vertical with vertical.(11)The mean gray level histogram values of the cone beam computed tomography at extraction socket will be obtained through digora software , gray scale is a digital photograpy , computer generated imagery and colorimetry . For each defect a regions of intrest can be created for the defect region and one the surrounding bone using the freehand selection tool, the minimum safety distance from one pixel to any cortical structure has to be ensured,after creating region of intrest the analysis is performed and result is transferred directly to statical analysis sheet,(Geiger, Blem et al. 2016) The difference in mean grey level values at study and control sites were tabulated and compared bone density. The purpose of using mandibular third molar because third molar is most commonly impacted teeth and routinly extracted with number of complications being reported and overcome these complication we are using CGF in third molar socket
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Procedure: Surgical extraction of impacted third molarAfter third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group |
| Control group | Experimental | Procedure: Surgical extraction of impacted third molarAfter extraction closure with silk 3.0 compare bone density with cases |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Both genders
- Age above 17 years
- Impacted mandibular third molar
Key exclusion criteria (5 listed)
- Teeth require closed extraction
- Significant medical history ( e.g. uncontrolled diabetes mellitus )
- Patients with history of radiotherapy and chemotherapy
- Bleeding disorders
- Any pathology like tumor and cyst 6. Developmental disorder 7. Previously operated any surgery of jaw 8. cigarette smokers 9. Maxillary third molar
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 |
|---|---|---|
| Surgical extraction of impacted third molarAfter surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture | Procedure or surgery | Case group, Control group |
Primary outcome
Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months
Time frame: 3 month and 6 month
Cases compare with control with help of cone beam computerized tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: Yes. Randmised control trial
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Periodontal Defect
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Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
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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.
D O W principal investigator
Dow University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extraction of impacted third molar in people with Impacted Third Molar Tooth, run by Dow University of Health Sciences at 2 sites 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months (time frame: 3 month and 6 month). 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 3 Aug 2023.