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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03501199
Other study ID # NecmettinEU-Dentistry
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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