Bone-Implant Contact Surface Influence on Dental Implant Stability

NCT06178796 | Completed

• 1 other identifier: MUDHF_CER_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth

Keywords

Dental implant, primary stability, immediate placement

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (3)

With graft

ACTIVE COMPARATOR

Device: Dental implant

Without graft

ACTIVE COMPARATOR

Device: Dental implant

Delayed healing site

ACTIVE COMPARATOR

Device: Dental implant

Interventions

Dental implant DEVICE

Dental implant placement

Delayed healing site; With graft; Without graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anodontia

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)