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Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery

Primary Purpose

Periodontal Pocket, Impacted Third Molar Tooth, Impacted Teeth With Abnormal Position

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Impacted third molar surgery
Application of mineralised plasmatic matrix
Application of β-tricalcium phosphate
Sponsored by
Konya Necmettin Erbakan Üniversitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket focused on measuring Mineralized Plasmatic Matrix, Beta-tricalcium phosphate

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Necmettin Erbakan University, Faculty of dentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mineralised Plasmatic Matrix Group

Beta-tricalcium phosphate Group

Control Group

Arm Description

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.

Beta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane.

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.

Outcomes

Primary Outcome Measures

Periodontal pocket depth
Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.
Alveolar bone level
Initial bone level measurement at the distal aspect of second molar tooth before extraction.

Secondary Outcome Measures

Periodontal pocket depth
Secondary measurement of periodontal pocket depth after extraction
Alveolar bone level
Secondary measurement of bone level after extraction

Full Information

First Posted
April 26, 2020
Last Updated
May 4, 2020
Sponsor
Konya Necmettin Erbakan Üniversitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04366635
Brief Title
Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Necmettin Erbakan Üniversitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Impacted Third Molar Tooth, Impacted Teeth With Abnormal Position
Keywords
Mineralized Plasmatic Matrix, Beta-tricalcium phosphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mineralised Plasmatic Matrix Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Beta-tricalcium phosphate Group
Arm Type
Experimental
Arm Description
Beta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Impacted third molar surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Application of mineralised plasmatic matrix
Other Intervention Name(s)
Application platelet rich fibrin membrane
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Application of β-tricalcium phosphate
Other Intervention Name(s)
Application platelet rich fibrin membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Periodontal pocket depth
Description
Initial periodontal pocket depth measurement at the distal aspect of second molar tooth before extraction.
Time Frame
At 0 day
Title
Alveolar bone level
Description
Initial bone level measurement at the distal aspect of second molar tooth before extraction.
Time Frame
At 0 day
Secondary Outcome Measure Information:
Title
Periodontal pocket depth
Description
Secondary measurement of periodontal pocket depth after extraction
Time Frame
At 6th month
Title
Alveolar bone level
Description
Secondary measurement of bone level after extraction
Time Frame
At 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Kılınç
Phone
03322230025
Email
dtalikilinc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kubilay Işık
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kubilay Işık
Organizational Affiliation
Consultant
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Kılınç
Organizational Affiliation
Care Provider
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University, Faculty of dentistry
City
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kubilay Işık

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Two Different Grafting Techniques After Mandibular Impacted Third Molar Surgery

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