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Clinical Trials/NCT06178796
NCT06178796CompletedNot Applicable

Bone-Implant Contact Surface Influence on Dental Implant Stability in Fresh Extraction and Healed Sites

Marmara University1 site in 1 country30 target enrollmentStarted: October 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Change in Implant Stability Quotient (ISQ) values

Study Overview

Brief Summary

This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago,
  • At least 18 years old,
  • Maintaining good dental hygiene,
  • Having a favorable occlusion,
  • Having intact socket walls after extraction.

Exclusion Criteria

  • Any local or systemic disorders that had contraindications for dental implant insertion,
  • Pregnant and lactating women.

Arms & Interventions

Without graft

Active Comparator

Intervention: Dental implant (Device)

Delayed healing site

Active Comparator

Intervention: Dental implant (Device)

With graft

Active Comparator

Intervention: Dental implant (Device)

Outcomes

Primary Outcomes

Change in Implant Stability Quotient (ISQ) values

Time Frame: 12 weeks

Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows: T0: baseline T1: follow-up of eight weeks T2: follow-up of twelve weeks

Change in bone-implant contact surface

Time Frame: 12 weeks

The tooth slated for extraction will be segmented from the preoperative CBCT data, followed by a virtual tooth extraction process. For each patient, intraoral surface scanning with the scanbodies in place will be conducted using an intraoral scanner. This datas will be overlaid onto the postoperative intraoral scan image. The area where the implant surface made contact with the extracted tooth surface will be identified as the surface without implant bone contact (BINC), while the remaining area will be designated the bone implant contact (BIC) surface. By subtracting the sum of the BINC and BIC from the entire implant surface, the implant surface facing the gap space (IGS) and its corresponding area on the BINC side will obtain. To isolate the BIC surface for measurement, the sum of the BINC and BIC from the sum of the BINC and IGS will subtracted. This result will then be added to the total implant surface measurement, divided by two, allowing for the measurement of the BIC surface.

Primary insertion torque value

Time Frame: 1 day At the implant placement

The torque value was recorded as insertion torque value of this case at the moment when the implant positioned at the 1mm under the socket wall edge and correct hex position. It gives numerical values from 0 to 100 (higher values mean higher stability).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ferit Bayram

Assist. Prof.

Marmara University

Study Sites (1)

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