Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability

Missing Teeth Clinical Trial

Official title:

Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178796
• Other study ID #: MUDHF_CER_01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

Device:
• Dental implant
Dental implant placement

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 one week T2: follow-up of eight weeks T3: follow-up of twelve weeks	12 weeks
Primary	Change in implant stability measured by Easy Check device	Easy check is an implant stability measuring device which gives similar outcome measurements with Ostell and has the advantage of application at any angle with disposable vinyl caps. It gives numerical values from 1 to 100 (higher values mean higher stability).	12 weeks
Primary	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