EVALUATION OF OSSEOINTEGRATION PROCESS OF DENTAL IMPLANTS

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06099834
Collaborator
(none)
19
1
3
28.9
0.7

Study Details

Study Description

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. We evaluated the osseointegration of different sizes with two devices measuring stability with different methods.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients selection
  • Other: Implnat placement
  • Other: Recall visits
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
EVALUATION OF OSSEOINTEGRATION PROCESS OF IMPLANTS WITH DIFFERENT LENGTH AND DIAMETER BY DIFFERENT METHODS
Actual Study Start Date :
Sep 14, 2018
Actual Primary Completion Date :
Nov 7, 2020
Actual Study Completion Date :
Feb 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Patient 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.

Other: Patients selection
Patient selection were selected according to selected criteria.

Other: Dental Implant Application

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.

Other: Implnat placement
dental implants were applied as recommended by the manufacturer.

Other: Osseointegration and periodontal measurements

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. RFA measurement [the 1st (T1), 4th (T4), and 12th (T12) weeks]

    two SmartPeg transducers were used on each implant, and three measurements were complet- ed: 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

  2. 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 [Figure 2] 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University, School of Dentistry Istanbul Turkey 34083

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Nur Balci, DDs, PhD, Associate Prof Dr, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT06099834
Other Study ID Numbers:
  • 256
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nur Balci, DDs, PhD, Associate Prof Dr, Istanbul Medipol University Hospital

Study Results

No Results Posted as of Oct 25, 2023