Bone-Implant Contact Surface Influence on Dental Implant Stability

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

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 Overview

• Status: Completed
• Conditions: Missing Teeth
• Intervention / Treatment: Device: Dental implant

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Marmara University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With graft	Device: Dental implant; Dental implant placement
Active Comparator: Without graft	Device: Dental implant; Dental implant placement
Active Comparator: Delayed healing site	Device: Dental implant; Dental implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary insertion torque value	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).	1 day At the implant placement
Change in Implant Stability Quotient (ISQ) values	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	12 weeks
Change in bone-implant contact surface	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.	12 weeks

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Dental implant, primary stability, immediate placement
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Tooth Loss; Anodontia
• Other Study ID Numbers: MUDHF_CER_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No