Periodontal PocketNCT04366635
Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery
A study testing Impacted third molar surgery, Application of mineralised plasmatic matrix and Application of β-tricalcium phosphate in people with Periodontal Pocket and Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effectiveness of using Mineralized Plasmatic Matrix and β-tricalcium phosphate that placed to extraction socket as a graft material in terms of periodontal damage occurred in the distal aspect of the second molar after mandibular impacted third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Impacted Third Molar Tooth, Impacted Teeth With Abnormal Position
- What is being tested?
- Impacted third molar surgery, Application of mineralised plasmatic matrix and Application of β-tricalcium phosphate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2020to 20 Aug 2020
- 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
- Medically healthy.
- Periodontally healthy patients.
- Patients with mesioangular or horizontal impacted teeth that will cause periodontal damage at the distal part of the second molar after surgery.
Who cannot join
- Crowns on second molar teeth.
- Poor oral hygiene.
- Patients with a systemic disease affecting periodontal healing.
- Pregnancy or lactation period.
- Patients undergoing orthodontic treatment.
- Smokers.
- The cases where the buccal or lingual cortical bone didn't remain intact following the extraction were also excluded.
Trial locations and contacts
1 site in 1 country.
Kubilay Işık contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University, Faculty of dentistry
Konya
Kubilay Işık
About this study
Official title: Evaluation of the Effectiveness of the Mineralized Plasmatic Matrix and Tricalcium Phosphate Graft Application After Mandibular Impacted Third Molar Surgery in Terms of Periodontal and Osseous Healing Distal to the Second Molar
This study evaluates the effectiveness of using Mineralized Plasmatic Matrix and β-tricalcium phosphate that placed to extraction socket as a graft material in terms of periodontal damage occurred in the distal aspect of the second molar after mandibular impacted third molar surgery.
- Being tested
- Impacted third molar surgery, Application of mineralised plasmatic matrix, Application of β-tricalcium phosphate
- Keywords
- Mineralized Plasmatic Matrix, Beta-tricalcium phosphate
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted third molar surgeryProcedure or surgery
Under local anesthesia, flap will be raised and mesioangular or horizontal impacted third molar tooth will be removed with routine technique. And then extraction socket will be irrigated with salin and will be primarily closed.
Application of mineralised plasmatic matrixProcedure or surgery
Also called Application platelet rich fibrin membrane
After extraction of impacted third molar tooth, Mineralized Plasmatic Matrix will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.
Application of β-tricalcium phosphateProcedure or surgery
Also called Application platelet rich fibrin membrane
After extraction of impacted third molar tooth, β-tricalcium phosphate will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.
| Study group | Role | What they receive |
|---|---|---|
| Mineralised Plasmatic Matrix Group | Experimental | Mineralized Plasmatic Matrix (MPM) is a product of mixing of two phases: the mineral phase and the plasma phase. After centrifugation, the white blood cells are recovered and mixed with the mineral phase of bone graft that can be autogenic, allogeneic bone, or a bone substitute like Xenogeneic Bone Synthetic. We will use Beta-tricalcium phosphate as a graft material. The result of this mixture is a homogeneous single component, which is compact and stable, containing the graft, the dense fibrin network, and the promoting healing. And then we are planning to place MPM material to extraction socket of impacted third molar tooth to improve periodontal healing at the distal aspect of second molar tooth. Additional after MPM places to extraction socket, Once the MPM has been placed, it will be covered with a Platelet Rich Fibrin (PRF) membrane and sutured as a primer. Receives: Procedure: Impacted third molar surgery; Procedure: Application of mineralised plasmatic matrix |
| Beta-tricalcium phosphate Group | Experimental | Beta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane. Receives: Procedure: Impacted third molar surgery; Procedure: Application of β-tricalcium phosphate |
| Control Group | Active comparator | In the control group, after removal of impacted third molar tooth no material will be placed on the extraction socket. Only the extraction socket was primarily closed with non-resorbable sutures. Receives: Procedure: Impacted third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.
Measured: At 0 day
Alveolar bone level
Initial bone level measurement at the distal aspect of second molar tooth before extraction.
Measured: At 0 day
Secondary outcomes (2)
Periodontal pocket depth
Secondary measurement of periodontal pocket depth after extraction
Measured: At 6th month
Alveolar bone level
Secondary measurement of bone level after extraction
Measured: At 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start27 Apr 2020
- Primary completion20 May 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kılınç, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Kubilay Işık, Study chair, ConsultantAli Kılınç, Study director, Care Provider
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366635
- Sponsor's protocol ID
- KonyaNEU1
- Status last verified
- May 2020
- First submitted
- 26 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Mineralized Plasmatic Matrix and Tricalcium Phosphate Graft Application After Mandibular Impacted Third Molar Surgery in Terms of Periodontal and Osseous Healing Distal to the Second Molar
- ClinicalTrials.gov ID
- NCT04366635
- Acronym / sponsor ID
- KonyaNEU1
- Keywords
- Mineralized Plasmatic Matrix, Beta-tricalcium phosphate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 29 Apr 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.
This study evaluates the effectiveness of using Mineralized Plasmatic Matrix and β-tricalcium phosphate that placed to extraction socket as a graft material in terms of periodontal damage occurred in the distal aspect of the second molar after mandibular impacted third molar surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mineralised Plasmatic Matrix Group | Experimental | Procedure: Impacted third molar surgery, Procedure: Application of mineralised plasmatic matrixMineralized Plasmatic Matrix (MPM) is a product of mixing of two phases: the mineral phase and the plasma phase. After centrifugation, the white blood cells are recovered and mixed with the mineral phase of bone graft that can be autogenic, allogeneic bone, or a bone substitute like Xenogeneic Bone Synthetic. We will use Beta-tricalcium phosphate as a graft material. The result of this mixture is a homogeneous single component, which is compact and stable, containing the graft, the dense fibrin network, and the promoting healing. And then we are planning to place MPM material to extraction socket of impacted third molar tooth to improve periodontal healing at the distal aspect of second molar tooth. Additional after MPM places to extraction socket, Once the MPM has been placed, it will be covered with a Platelet Rich Fibrin (PRF) membrane and sutured as a primer. |
| Beta-tricalcium phosphate Group | Experimental | Procedure: Impacted third molar surgery, Procedure: Application of β-tricalcium phosphateBeta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane. |
| Control Group | Active comparator | Procedure: Impacted third molar surgeryIn the control group, after removal of impacted third molar tooth no material will be placed on the extraction socket. Only the extraction socket was primarily closed with non-resorbable sutures. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically healthy.
- Periodontally healthy patients.
- Patients with mesioangular or horizontal impacted teeth that will cause periodontal damage at the distal part of the second molar after surgery.
Key exclusion criteria (7 listed)
- Crowns on second molar teeth.
- Poor oral hygiene.
- Patients with a systemic disease affecting periodontal healing.
- Pregnancy or lactation period.
- Patients undergoing orthodontic treatment.
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 |
|---|---|---|
| Impacted third molar surgeryUnder local anesthesia, flap will be raised and mesioangular or horizontal impacted third molar tooth will be removed with routine technique. And then extraction socket will be irrigated with salin and will be primarily closed. | Procedure or surgery | Beta-tricalcium phosphate Group, Control Group, Mineralised Plasmatic Matrix Group |
| Application of mineralised plasmatic matrixAlso: Application platelet rich fibrin membraneAfter extraction of impacted third molar tooth, Mineralized Plasmatic Matrix will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed. | Procedure or surgery | Mineralised Plasmatic Matrix Group |
| Application of β-tricalcium phosphateAlso: Application platelet rich fibrin membraneAfter extraction of impacted third molar tooth, β-tricalcium phosphate will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed. | Procedure or surgery | Beta-tricalcium phosphate Group |
Primary outcome
Periodontal pocket depth
Time frame: At 0 day
Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.
Alveolar bone level
Time frame: At 0 day
Initial bone level measurement at the distal aspect of second molar tooth before extraction.
2 secondary outcomes
Periodontal pocket depth
Time frame: At 6th month
Alveolar bone level
Time frame: At 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- 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.
Kubilay Işık contact
Kubilay Işık study chair
Consultant
Ali Kılınç study director
Care Provider
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacted third molar surgery, Application of mineralised plasmatic matrix and Application of β-tricalcium phosphate in people with Periodontal Pocket and Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi 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 3 inclusion and 7 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 6 May 2020. 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. 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?
Contact Ali Kılınç (03322230025, dtalikilinc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depth (time frame: At 0 day). 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?
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 6 May 2020.