Dental ImplantNCT06715722
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures
A study testing hexed non hexed and non-hexed non-hexed in people with Dental Implant, run by University of Jordan at 1 site in Jordan.
Trial summary
This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- hexed non hexed and non-hexed non-hexed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJordan
- Study dates
- 11 Nov 2024to 10 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
- Candidates for an implant supported FDP in the posterior mandible.
- Teeth in area of interest extracted at least 3 months prior.
- Bone grafting not needed or only minor GBR needed.
- Controlled oral hygiene.
- Sufficient bone volume.
Who cannot join
- Patients with edentulous span of less than 3 missing teeth (not eligible to receive a 3 unit 2 implant supported FDP)
- Patients with healing period of extraction sites less than 3 months.
- Extensive bone grafting required prior to or during implant placement.
- Active Bruxism.
- Heavy smoker (> 10 cigarettes).
- Systemic diseases that might affect bone healing.
- Patients who are not willing or unable to give consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University Hospital
Amman
Mohammad A AL-Rababáh, 00962792131548, malrababah@ju.edu.jo
About this study
Official title: Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications.
Read the detailed description
Study design:
This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.
The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, patients who will receive 2 internal connection dental implants to replace 3 posterior missing teeth in the mandible with a 3 unit screw-retained FDP with sufficient bone volume and controlled oral hygiene. The intervention group will receive a screw-retained FDP with conical engaging and non engaging abutment configuration, while the comparator group will a screw-retained FDP with both conical non engaging abutment configuration. The primary outcome is changes in marginal bone levels, and the secondary outcomes include technical and mechanical complications, biological complications, and patient satisfaction.
Both groups will receive 2 internal connection implants in the posterior mandible in healed sites of at least 3 months (guided implant surgery). The surgical procedure will follow standardized protocols, with no variations between groups other than the types of implant abutment connections used.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: definitive loading, after 6 months of loading, after 2 years loading.
- Conditions
- Dental Implant
- Being tested
- hexed non hexed, non-hexed non-hexed
- Keywords
- Implant abutment connection, Dental implant, Fixed dental prosthesis, Engaging abutment, Non-engaging abutment, Conical connections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hexed non hexedDevice
A 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment.
non-hexed non-hexedDevice
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
| Study group | Role | What they receive |
|---|---|---|
| hexed non hexed | Experimental | a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using hexed and non hexed abutments Receives: Device: hexed non hexed |
| non hexed non hexed | Active comparator | a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments Receives: Device: non-hexed non-hexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
Marginal bone level changes by standardized periapical radiographs.
Measured: Baseline (day of definitive loading) and at 1-year follow-up post-loading.
Secondary outcomes (3)
Technical or mechanical complications
screw loosening, screw fracture, abutment or implant fracture, prosthesis fracture or chipping
Measured: 1 year
Biological complications
Peri implant bone loss, early implant failure.
Measured: 1 year
Patient satisfaction
To be assesses by oral health impact profile-14 (OHIP-14), The scale includes 14 items covering various aspects of oral health-related quality of life, Score Range: from 0 to 56, Higher OHIP-14 scores indicate a worse outcome, representing a greater negative impact of oral health issues on quality of life, while lower scores suggest a better outcome or less impact on the individual's daily life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start11 Nov 2024
- Primary completion20 Jul 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad AL-Rababáh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715722
- Sponsor's protocol ID
- 10/2024/28042
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06715722
- Acronym / sponsor ID
- 10/2024/28042
- Conditions
- Dental Implant
- Keywords
- Implant abutment connection, Dental implant, Fixed dental prosthesis, Engaging abutment, Non-engaging abutment, Conical connections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 4 Dec 2024 (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.
This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications.
Detailed description
Study design:
This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.
The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, patients who will receive 2 internal connection dental implants to replace 3 posterior missing teeth in the mandible with a 3 unit screw-retained FDP with sufficient bone volume and controlled oral hygiene. The intervention group will receive a screw-retained FDP with conical engaging and non engaging abutment configuration, while the comparator group will a screw-retained FDP with both conical non engaging abutment configuration. The primary outcome is changes in marginal bone levels, and the secondary outcomes include technical and mechanical complications, biological complications, and patient satisfaction.
Both groups will receive 2 internal connection implants in the posterior mandible in healed sites of at least 3 months (guided implant surgery). The surgical procedure will follow standardized protocols, with no variations between groups other than the types of implant abutment connections used.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: definitive loading, after 6 months of loading, after 2 years loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hexed non hexed | Experimental | Device: hexed non hexeda 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using hexed and non hexed abutments |
| non hexed non hexed | Active comparator | Device: non-hexed non-hexeda 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
- Candidates for an implant supported FDP in the posterior mandible.
- Teeth in area of interest extracted at least 3 months prior.
- Bone grafting not needed or only minor GBR needed.
- Controlled oral hygiene.
Key exclusion criteria (7 listed)
- Patients with edentulous span of less than 3 missing teeth (not eligible to receive a 3 unit 2 implant supported FDP)
- Patients with healing period of extraction sites less than 3 months.
- Extensive bone grafting required prior to or during implant placement.
- Active Bruxism.
- Heavy smoker (> 10 cigarettes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hexed non hexedA 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment. | Device | hexed non hexed |
| non-hexed non-hexeda 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments | Device | non hexed non hexed |
Primary outcome
Marginal Bone Loss
Time frame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.
Marginal bone level changes by standardized periapical radiographs.
3 secondary outcomes
Technical or mechanical complications
Time frame: 1 year
Biological complications
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
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 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Implant
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hexed non hexed and non-hexed non-hexed in people with Dental Implant, run by University of Jordan at 1 site in Jordan.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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 Jordan. 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?
Contact Mohammad A AL-Rababáh (00962792131548, malrababah@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Bone Loss (time frame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.