Clinical trial NCT06800508: Primary and Secondary Stability of a One-Piece Compressive Implant System
Official title: Comparison of Primary and Secondary Stability of a One-Piece Compressive Conometric Implant System in a Posterior Upper and Lower Jaw Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dental Implant
Keywords: Dental implant
primary stability
secondary stability
Compressive Implant
Conometric
One-piece implant
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seeking dental implant for missing teeth.

Brief summary: Implant stability plays a major role in establishing implant osseointegration; it is considered an important requirement to decide the functional loading time with a fixed prosthesis. Objectives: to investigate the influence of one-piece implant position on their primary and secondary stability. The implant gains its Primary stability at placement time as a mechanical phenomenon that is related to the type of implant, placement technique used, and the local bone quality and quantity whereas, secondary stability is attributable to bone formation at the implant/tissue interface and in the surrounding bone. This study compares the stability of a compressive Conometric implant designed by Trade Company (ROOTT compressive with Conometric) in the posterior upper and lower jaws and optimizes the time of functional loading. This study's hypothesis is that implant stability is unaffected by the implant's position within the mouth cavity.

Detailed description: Although Implant stability plays a major role in establishing the implant osseointegration, it is considered an important requirement to decide the functional loading time with a fixed prosthesis. Controlled loading is beneficial to maintain the implant stability during the early stage of healing as determined by resonance frequency analysis (RFA) measurement. There are different methods to determine implant stability, clinically examining the mobility by manual instrument, insertion torque value (ITV), electronic instrument, and radiograph evaluation of the bone around the implant; researchers found these are not sensitive enough. The introduction of quantitative methods, including the use of an RFA device (Osstell ISO, Integration Diagnostics AB, Gothenburg, Sweden) to measure implant stability, can yield valuable information, and its value range100. In contrast, a value greater than 70 is considered to indicate higher implant stability. Damping Capacity Analysis (DCA) device (Periotest; Medizintectechnik Gulden, Modautal, Germany) is another noninvasive method introduced to measure implant stability. Recently, Anycheck ( Neobiotech Seoul, Korea) is a modified DCA device introduced to measure implant stability, and Its value ranges from 1 to 99. Implant stability values of 1-59 were considered low stability; values of 60-64 indicated moderate stability; and values above 65 indicated high stability. The implant gains its Primary stability at placement time as a mechanical phenomenon that is related to the type of implant, placement technique used, and the local bone quality and quantity whereas, secondary stability is attributable to bone formation at the implant/tissue interface and in the surrounding bone. evaluated two-implant system stability using Periotest four months after the implant placement showed a mean of -1.9 for system A and mean of -2.1 system B whereas, Negative readings denote higher stiffness and a higher degree of osseointegration which indicated that implants were well osseointegrated and stable. Searching literature shows that applying different approaches to immediate loading can lead to survival rates in controlled studies comparable with those of conventionally loaded implants- however, this study is based on a small number. The selection of implant retained prosthesis type is a challenge for the dentist. Commonly there are different types of prosthesis retained to fixtures such as removable with precision attachment to the fixture and fixed restoration retained to the fixture either with cement or screw. Both cement and screw-retained fixtures have advantages and disadvantages like loos screw from time to time and remnant of cement under the restoration that leads to ridge mucous trauma. Conometric is another method to achieve retention of the prosthesis to the implant abutment, in addition to conventional cement and screw-based methods. Conometric works on the principle of frictional contact and elastic deformation of the connecting coping. Morse taper Conometric system used as implant-supported fixed dental prostheses retention found that the taper Conometric system can provide a retentive performance between implants and dental prostheses if proper insertion force is applied compared with cemented type without compromising the mechanical functionality of the system. Introduction One-piece implants with compressive threads, by ROOTT Implant Company, can be used for multiple units' restoration with immediate loading when adequate bone tissue is available. Studying the stability of a one-piece and comparing it to a two-piece implant suggested that both implant systems are clinically successful for dental rehabilitation and give consistent, longstanding results. Recently, this compressive implant was introduced with Conometric titanium caps (TEC) of different sizes and lengths. This study was conducted to compare the stability of a compressive Conometric implant designed by Trade Company (ROOTT compressive with Conometric) in the posterior upper and lower jaws and optimize the time of functional loading. This study's hypothesis is that implant stability is unaffected by the implant's position within the mouth cavity.

Eligibility criteria: Inclusion Criteria:

1. participating in this study already they are visiting the practice seeking implants to replace their missing teeth.
2. All teeth that want to be replaced with an implant should be extracted for more than two months.
3. Having enough height and width of alveolar bone to allow dental implant placement.

Exclusion Criteria:

1. Patients with systemic disease that could promise osseointegration.
2. Patients received radiation therapy in the head and neck region within the previous 12 months.
3. Smoker more than 10 cigarettes per day.
4. pregnant or lactating.
5. previous treatment with bisphosphonates.
6. presence of active periodontics infection.

Primary outcomes:
measure: Primary dental implant stability
timeFrame: immediately after dental implant insertion as base line then at 3 and 6 month.
Secondary outcomes:
measure: Secondary dental implant stability
timeFrame: 3 and 6 months after dental implant insertion.
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: A to Z dental care center
Study officials:
affiliation: University of Sulaimani
name: Sarhang S Gul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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