Comparison of Different Materials Contribution to Implants Stability

Dental Implant Failure Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501199
• Other study ID #: NecmettinEU-Dentistry
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 4, 2019

Study information

• Verified date: December 2018
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 4, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant Failure Nos

Intervention

Other:
• platelet-rich fibrin placement
filling the buccal gap with platelet-rich fibrin after immediate dental implant placement
• xenogenic graft placement
filling the buccal gap with xenogenic graft after immediate dental implant placement
• no extra material
filling the buccal gap with no material after immediate dental implant placement

Procedure:
• tooth extraction
extraction of tooth which is unrestorable
• 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

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University, Faculty of dentistry	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primer Stabilization-Resonance Frequency Analysis	initial measurement after placement by Osstell device	at 0 day
Secondary	Seconder Stabilization-Resonance Frequency Analysis	secondary measurement after placement by Osstell device	120th day
Secondary	Mesial-Distal and Horizontal Bone Loss	The alveolar bone loss between first day to 9th month	9th month