Comparison of Different Materials Contribution to Implants Stability

Comparison of Different Materials Contribution to Immediate Implants Stability With Resonance Frequency Analysis

The investigators will use two types of material(PRF-Xenograft) in the buccal gap after immediate dental implant placement. The study design has three groups PRF, graft, and control group. The patients will randomly be assigned to groups by envelop method. The resonance frequency analysis device(Osstell) will be used to measure primary and secondary stabilization. Then the investigators will evaluate each materials' contribution to stability.

Pre-op and 9th month Post-op CBCTs will evaluate about bone loss in mesial-distal and horizontal dimensions.

Study Overview

• Status: Completed
• Conditions: Dental Implant Failure Nos
• Intervention / Treatment: Other: platelet-rich fibrin placement; Procedure: tooth extraction; Procedure: immediate implant placement; Other: collagen membran placement; Procedure: raising flap; Other: xenogenic graft placement; Other: no extra material

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• medically healthy,
• only one maxillary aesthetic region(incisors or premolars) tooth which has two adjacent teeth is indicated for extraction.
• intact buccal socket walls
• the gap between buccal socket wall to implant sholder at least 2 mm.

Exclusion Criteria:

• relevant tooth has more than one root,
• smoking,
• alcohol abuse,
• pregnancy,
• immune-suppressive patients,
• any systemic disease.

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: PRF Group; PRF is will be used in immediate dental implant placement.	Other: platelet-rich fibrin placement; filling the buccal gap with platelet-rich fibrin after immediate dental implant placement; Procedure: tooth extraction; extraction of tooth which is unrestorable; Procedure: immediate implant placement; putting dental implant into a socket which has been prepared with compatible drills; Other: collagen membran placement; placing collagen membran on extraction socket after dental implant placement to cover all; Procedure: raising flap; raising the buccal flap with two vertical incision to cover extraction socket for primary closure
Experimental: Graft Group; The xenogenic graft is will be used in immediate dental implant placement.	Procedure: tooth extraction; extraction of tooth which is unrestorable; Procedure: immediate implant placement; putting dental implant into a socket which has been prepared with compatible drills; Other: collagen membran placement; placing collagen membran on extraction socket after dental implant placement to cover all; Procedure: raising flap; raising the buccal flap with two vertical incision to cover extraction socket for primary closure; Other: xenogenic graft placement; filling the buccal gap with xenogenic graft after immediate dental implant placement
Experimental: Control Group; No extra material is will be used in immediate dental implant placement.	Procedure: tooth extraction; extraction of tooth which is unrestorable; Procedure: immediate implant placement; putting dental implant into a socket which has been prepared with compatible drills; Other: collagen membran placement; placing collagen membran on extraction socket after dental implant placement to cover all; Procedure: raising flap; raising the buccal flap with two vertical incision to cover extraction socket for primary closure; Other: no extra material; filling the buccal gap with no material after immediate dental implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primer Stabilization-Resonance Frequency Analysis	initial measurement after placement by Osstell device	at 0 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seconder Stabilization-Resonance Frequency Analysis	secondary measurement after placement by Osstell device	120th day
Mesial-Distal and Horizontal Bone Loss	The alveolar bone loss between first day to 9th month	9th month

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Chair: Alparslan Esen, Consultant; Study Director: Gökhan Gürses, Care Provider

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: immediate implant placement
• Other Study ID Numbers: NecmettinEU-Dentistry

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