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

NCT ID: NCT04366635

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2020-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Pocket Impacted Third Molar Tooth Impacted Teeth With Abnormal Position

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mineralised Plasmatic Matrix Group

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.

Group Type EXPERIMENTAL

Impacted third molar surgery

Intervention Type PROCEDURE

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 matrix

Intervention Type PROCEDURE

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.

Beta-tricalcium phosphate Group

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

Group Type EXPERIMENTAL

Impacted third molar surgery

Intervention Type PROCEDURE

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 β-tricalcium phosphate

Intervention Type PROCEDURE

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.

Control Group

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.

Group Type ACTIVE_COMPARATOR

Impacted third molar surgery

Intervention Type PROCEDURE

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.

Interventions

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Impacted third molar 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.

Intervention Type PROCEDURE

Application of mineralised plasmatic matrix

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

Application of β-tricalcium phosphate

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.

Intervention Type PROCEDURE

Other Intervention Names

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Application platelet rich fibrin membrane Application platelet rich fibrin membrane

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Ali Kılınç

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kubilay Işık

Role: STUDY_CHAIR

Consultant

Ali Kılınç

Role: STUDY_DIRECTOR

Care Provider

Locations

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Necmettin Erbakan University, Faculty of dentistry

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ali Kılınç

Role: CONTACT

03322230025

Kubilay Işık

Role: CONTACT

Facility Contacts

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Kubilay Işık

Role: primary

Other Identifiers

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KonyaNEU1

Identifier Type: -

Identifier Source: org_study_id

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