Primary and Secondary Stability of a One-Piece Compressive Implant System

NCT06800508 | Active Not Recruiting DMC

• 1 other identifier: 227/24
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

Dental implant; primary stability; secondary stability; Compressive Implant; Conometric; One-piece implant

Outcome Measures

Primary Outcomes (1)

• Primary dental implant stability

  Dental implant stability will be measured by resonance frequency analysis.

  immediately after dental implant insertion as base line then at 3 and 6 month.

Secondary Outcomes (1)

• Secondary dental implant stability

  3 and 6 months after dental implant insertion.

Study Arms (1)

One-piece implant

Preoperative CBCT for the implant area will be taken for analysis of anatomical features for all patients. Elastomeric impression will be obtained of both maxillary and mandibular arches, laboratory stone study casts will be made, and acrylic with metal sleeve surgical guide will be fabricated to localize the implant insertion position in the jaw bone without flap. After the administration of infiltration local anesthesia, the surgical guide will be fixed in its position on the jaw arch, and a drilling sequence will be applied according to the manufacturer's instructions to create a hole for implant placement. The compressive one-piece implant (fixture and abutment) from ROOTT Trade Company will be inserted with appropriate neck and abutment length. The implant insertion torque will be adjusted to 35 Ncm by the wrench.

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects seeking dental implant for missing teeth.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

A to Z dental care center

Sulaymaniyah, 46001, Iraq

Location

Related Publications (1)

• Claudino D, Traebert J. Malocclusion, dental aesthetic self-perception and quality of life in a 18 to 21 year-old population: A cross section study. BMC Oral Health. 2013;13:2-7. https://doi.org/10.1186/1472-6831-13-3 Ali MA, Yassir YA. Mandibular Clinical Arch Forms in Iraqi Population: A National Survey. Diagnostics. 2022;12:1-15. https://doi.org/10.3390/diagnostics12102352 Najm AA, Mahdi AS, Al-Sudani RJ. Prevalence of Dental Anomalies among Iraqi Dental Students. J Baghdad Coll Dent. 2016;28:72-6. https://doi.org/10.12816/0033214 Moreno Uribe LM, Miller SF. Genetics of the dentofacial variation in human malocclusion. Orthod Craniofacial Res. 2015;18:91-9. https://doi.org/10.1111/ocr.12083 Staudt CB, Kiliaridis S. Different skeletal types underlying Class III malocclusion in a random population. Am J Orthod Dentofac Orthop. 2009;136:715-21. https://doi.org/10.1016/j.ajodo.2007.10.061 Abdulhussein ZA, Aksoy A. Compliance of Patients with Class III Malocclusion to Orthodontic Treatment. J Baghdad Coll Dent. 2022;34:12-24. https://doi.org/10.26477/jbcd.v34i1.3087 Mossey PA. The heritability of malocclusion: Part 1--Genetics, principles and terminology. Br J Orthod. 1999;26:103-13. https://doi.org/10.1093/ortho/26.2.103 Xue F, Wong RWK, Rabie ABM. Genes, genetics, and Class III malocclusion. Orthod Craniofacial Res. 2010;13:69-74. https://doi.org/10.1111/j.1601-6343.2010.01485.x Hussein AS, Porntaveetus T, Abid M. The association of polymorphisms in BMP2/MYO1H and skeletal Class II div.1 maxillary and mandibular dimensions. A preliminary 'report. Saudi J Biol Sci. 2022;29:1-7. https://doi.org/10.1016/j.sjbs.2022.103405 Manolio TA. Genomewide Association Studies and Assessment of the Risk of Disease. N Engl J Med. 2010;363:166-76. https://doi.org/10.1056/NEJMra0905980 Weiler CA, Drumm ML. Genetic influences on cystic fibrosis lung disease severity. Front Pharmacol. 2013;4:1-19. https://doi.org/10.3389/fphar.2013.00040 Strauss JF, Romero R, Gomez-Lopez N, Haymond-Thornburg H, Modi BP, Teves ME, et al. Spontaneous Preterm Birth: Advances toward the Discovery of Genetic Predisposition. Am J Obstet Gynecol. 2018;218:294-314. https://doi.org/10.1016/j.ajog.2017.12.009 Weaver CA. Candidate Gene Analysis of 3D Dental Phenotypes in Patients with Malocclusion. University of Iowa; 2014. Little J, Higgins JPT, Ioannidis JPA, Moher D, Gagnon F, Elm EV, et al. STrengthening the REporting of genetic association studies (STREGA)- An extension of the STROBE statement. Genet Epidemiol. 2009;33:581-98. https://doi.org/10.1002/gepi.20410 Steiner CC. Cephalometrics for you and me. Am J Orthod. 1953;39:729-55. https://doi.org/10.1016/0002-9416(53)90082-7 Guo L, Feng Y, Guo HG, Liu BW, Zhang Y. Consequences of orthodontic treatment in malocclusion patients: Clinical and microbial effects in adults and children. BMC Oral Health. 2016;16:1-7. https://doi.org/10.1186/s12903-016-0308-7

  RESULT

Study Officials

• Sarhang S Gul, PhD

  University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)