Dental ImplantNCT06800508
Primary and Secondary Stability of a One-Piece Compressive Implant System
An observational study of Dental Implant, run by University of Sulaimani at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- How many people
- 14 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2025to 1 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects seeking dental implant for missing teeth.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dental Implant
- Keywords
- Dental implant, primary stability, secondary stability, Compressive Implant, Conometric, One-piece implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary dental implant stability
Dental implant stability will be measured by resonance frequency analysis.
Measured: immediately after dental implant insertion as base line then at 3 and 6 month.
Secondary outcomes (1)
Secondary dental implant stability
Dental implant stability will be measured by resonance frequency analysis.
Measured: 3 and 6 months after dental implant insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jan 2025
- Primary completion15 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarhang Gul, University of Sulaimani
- Investigators
- Sarhang S Gul, PhD, Principal investigator, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800508
- Sponsor's protocol ID
- 227/24
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymous data about the participants will be reported in the study.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06800508
- Acronym / sponsor ID
- 227/24
- Conditions
- Dental Implant
- Keywords
- Dental implant, primary stability, secondary stability, Compressive Implant, Conometric, One-piece implant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects seeking dental implant for missing teeth.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary dental implant stability
Time frame: immediately after dental implant insertion as base line then at 3 and 6 month.
Dental implant stability will be measured by resonance frequency analysis.
1 secondary outcome
Secondary dental implant stability
Time frame: 3 and 6 months after dental implant insertion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publicationClaudino 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
- Individual participant dataSharing planned: No. Only anonymous data about the participants will be reported in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarhang S Gul, PhD principal investigator
University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant, run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary dental implant stability (time frame: immediately after dental implant insertion as base line then at 3 and 6 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.