Evaluation of Osseointegration Process of Dental Implants

Not Applicable

Completed

• Conditions: Dental Implant Failed; Osseointegration Failure of Dental Implant
• Interventions: Other: Recall visits; Other: Patients selection; Other: Implnat placement

• Registration Number: NCT06099834
• Lead Sponsor: Istanbul Medipol University Hospital

Brief Summary

Implant stability is critical to successful osseointegration, the direct structural connection between the dental implant surface and bone. Implant stability must therefore be measured to evaluate implant success. The study evaluated the osseointegration of different sizes with two devices measuring stability with different methods.

Detailed Description

The 39 implants, 4.0 and 4.5 mm in diameter and 10 and 12 mm in length, in 19 patients were included. Hounsfield unit (HU) values obtained on cone beam computed tomography (CBCT) were recorded. Stabilities were measured with Periotest and resonance frequency analysis (RFA) at day 0 (intra-operative) and the 1st (T1), 4th (T4), and 12th (T12) weeks. Probing depth (PD) and bleeding on probing (BOP) scores were compared between T1 and T4.

Study Timeline

• Study Start: 2018-09-14
• Primary Completion: 2020-11-07
• Study Completion: 2021-02-11
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Absence of any systemic disease
• being older than 20 years of age
• having partial tooth deficiency in the posterior region of the lower jaw (molar tooth deficiency)
• having an indication for dental implant-supported fixed prosthesis
• at least 6 months had elapsed since the last tooth extraction in the area to be implanted
• having a soft tissue thickness of at least 1.5 mm and adherent gingival width of at least 2 mm
• the existence of panoramic and dental volumetric tomography images of the area to be implanted
• the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter
• completion of periodontal treatment and provision of oral hygiene training; and acceptable existing gingival health and oral hygiene for implant application (periodontally healthy) in the oral examinations performed following periodontal treatment.

Exclusion Criteria

• being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseointegration and periodontal measurements	Recall visits	Following the operations, the stability of the dental implants was measured at the 1st (T1), 4th (T4), and 12th (T12) weeks using Periotest (Periotest M, Modautal/Germany) and Osstell (Osstell AB-W\&H, Sweden) devices. In accordance with the manufacturers' recommendations, the final implant stability quotient (ISQ) and Periotest values were determined by calculating the average of three measurements per implant. At the same time, periodontal index values of probing depth (PD-mm) and bleeding on probing (BOP-%) were recorded at the site of the dental implant at T4 and T12.
Patient selection	Patients selection	Patient selection criteria were as follows: absence of any systemic disease; not being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System (Doyle, 2017); being older than 20 years of age; the existence of panoramic and dental volumetric tomography images of the area to be implanted; the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter.
Dental Implant Application	Implnat placement	Bredent SKY® dental implants were applied at a torque level of 30 N.cm as recommended by the manufacturer. The surgery and all measurements were performed by the same surgeon.

Primary Outcome Measures

Name	Time	Method
RFA measurement	the 1st (T1), 4th (T4), and 12th (T12) weeks	two SmartPeg transducers were used on each implant, and three measurements were completed: therefore, total number of registers was six for each implant. All assessment was carried out consecutively regardless register time or location. Measurements were completed by one only experienced dentist with knowl- edge of the Osstell ISQ system for RFA assessment
Periotest measurement	the 1st (T1), 4th (T4), and 12th (T12) weeks	The periotest device is placed in a horizontal position 0.6-2 mm away from the tooth surface and two PTVs (PTV1 and PTV2) were calculated with a time difference of 20 min. During each measurement, the device delivers 16 impacts in 4 s to the object.

Secondary Outcome Measures

Name	Time	Method
Pocket probing depth	he 1st (T1), 4th (T4), and 12th (T12) weeks	Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

Trial Locations

Locations (1)

Istanbul Medipol University, School of Dentistry; 🇹🇷 Istanbul, Turkey