Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery
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
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2020
CompletedStudy Start
First participant enrolled
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedMay 6, 2020
May 1, 2020
23 days
April 26, 2020
May 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Periodontal pocket depth
Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.
At 0 day
Alveolar bone level
Initial bone level measurement at the distal aspect of second molar tooth before extraction.
At 0 day
Secondary Outcomes (2)
Periodontal pocket depth
At 6th month
Alveolar bone level
At 6th month
Study Arms (3)
Mineralised Plasmatic Matrix Group
EXPERIMENTALMineralized 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
EXPERIMENTALBeta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane.
Control Group
ACTIVE COMPARATORIn 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necmettin Erbakan University, Faculty of dentistry
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kubilay Işık
Consultant
- STUDY DIRECTOR
Ali Kılınç
Care Provider
Central Study Contacts
Kubilay Işık
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
April 26, 2020
First Posted
April 29, 2020
Study Start
April 27, 2020
Primary Completion
May 20, 2020
Study Completion
August 20, 2020
Last Updated
May 6, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share