Clinical trial NCT06099834: Evaluation of Osseointegration Process of Dental Implants
Official title: Evaluation of Osseointegration Process of Implants With Different Length And Diameter By Different Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failed
Osseointegration Failure of Dental Implant
Keywords: osseointegration
dental implant
mobility
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: RFA measurement
timeFrame: the 1st (T1), 4th (T4), and 12th (T12) weeks
measure: Periotest measurement
timeFrame: the 1st (T1), 4th (T4), and 12th (T12) weeks
Secondary outcomes:
measure: Pocket probing depth
timeFrame: he 1st (T1), 4th (T4), and 12th (T12) weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
Study officials:
References:
citation: Abrahamsson I, Linder E, Lang NP. Implant stability in relation to osseointegration: an experimental study in the Labrador dog. Clin Oral Implants Res. 2009 Mar;20(3):313-8. doi: 10.1111/j.1600-0501.2008.01646.x.
citation: Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
citation: Boronat Lopez A, Balaguer Martinez J, Lamas Pelayo J, Carrillo Garcia C, Penarrocha Diago M. Resonance frequency analysis of dental implant stability during the healing period. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E244-7.