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

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 Overview

• Status: Unknown
• Conditions: Impacted Third Molar Tooth; Periodontal Pocket; Impacted Teeth With Abnormal Position
• Intervention / Treatment: Procedure: Impacted third molar surgery; Procedure: Application of mineralised plasmatic matrix; Procedure: Application of β-tricalcium phosphate

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Recruiting
    • Necmettin Erbakan University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; 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.; Other Names: Application platelet rich fibrin membrane
Experimental: Beta-tricalcium phosphate Group; Beta-tricalcium phosphate graft will place in the extraction socket and cover with a PRF membrane.	Procedure: 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.; 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.; Other Names: Application platelet rich fibrin membrane
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal pocket depth	Secondary measurement of periodontal pocket depth after extraction	At 6th month
Alveolar bone level	Secondary measurement of bone level after extraction	At 6th month

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi
• Investigators: Study Chair: Kubilay Işık, Consultant; Study Director: Ali Kılınç, Care Provider

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): August 20, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Mineralized Plasmatic Matrix, Beta-tricalcium phosphate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Periodontitis; Tooth, Impacted; Periodontal Pocket
• Other Study ID Numbers: KonyaNEU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No