Comparison of Different Materials Contribution to Implants Stability

• ClinicalTrials.gov Identifier: NCT03501199
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: March 5, 2019
• Sponsor: Necmettin Erbakan University
• Information provided by (Responsible Party): Gökhan Gürses, Necmettin Erbakan University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Dental Implant Failure Nos	Other: platelet-rich fibrin placement; Other: xenogenic graft placement; Other: no extra material; Procedure: tooth extraction; Procedure: immediate implant placement; Other: collagen membran placement; Procedure: raising flap	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Different Materials Contribution to Immediate Implants Stability With Resonance Frequency Analysis
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: March 4, 2019

Arms and Interventions

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.	Other: xenogenic graft placement; filling the buccal gap with xenogenic graft 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: Control Group; No extra material is will be used in immediate dental implant placement.	Other: no extra material; filling the buccal gap with no material 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

Outcome Measures

Primary Outcome Measures :

1. Primer Stabilization-Resonance Frequency Analysis [ Time Frame: at 0 day ]
   initial measurement after placement by Osstell device

Secondary Outcome Measures :

1. Seconder Stabilization-Resonance Frequency Analysis [ Time Frame: 120th day ]
   secondary measurement after placement by Osstell device
2. Mesial-Distal and Horizontal Bone Loss [ Time Frame: 9th month ]
   The alveolar bone loss between first day to 9th month

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Turkey

Necmettin Erbakan University, Faculty of dentistry

Konya, Turkey

Sponsors and Collaborators

Necmettin Erbakan University

Investigators

• Study Chair: Alparslan Esen; Consultant
• Study Director: Gökhan Gürses; Care Provider

More Information

• Responsible Party: Gökhan Gürses, Research Assistant, Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT03501199
• Other Study ID Numbers: NecmettinEU-Dentistry
• First Posted: April 18, 2018
• Last Update Posted: March 5, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Gökhan Gürses, Necmettin Erbakan University:

immediate implant placement