Dental ImplantNCT06693297
Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns
A study testing Immediate loading of early placed implants and Conventional loading of early placed implants in people with Dental Implant, run by University of Jordan at 1 site in Jordan.
Trial summary
This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants. The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and… 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?
- Immediate loading of early placed implants and Conventional loading of early placed implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 25 Sep 2024to Sep 2026
- 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
- aged 18 years or older
- requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)
- having adequate bone volume
- controlled oral hygiene
- having agreed to take part in the study and willing to comply with the study protocol and follow-up visits
Who cannot join
- Any systemic condition that might jeopardize implant surgery
- history of radiation therapy to the head and neck region
- history of bisphosphonate therapy or other medications that may affect bone metabolism
- smoking more than 10 cigarettes/day
- history of bruxism or parafunctional habits
- localized/generalized periodontitis
- patients in need of bone grafting
- any known allergy or hypersensitivity to implant materials
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: Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial
This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants.
The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.
Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.
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, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.
Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.
- Conditions
- Dental Implant
- Being tested
- Immediate loading of early placed implants, Conventional loading of early placed implants
- Keywords
- dental implant, thread design, immediate loading, conventional loading, early placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loading of early placed implantsDevice
Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
Conventional loading of early placed implantsDevice
Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
| Study group | Role | What they receive |
|---|---|---|
| Conventional loading of early placed implants | Active comparator | Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement ) Receives: Device: Immediate loading of early placed implants; Device: Conventional loading of early placed implants |
| Immediate loading of early placed implants | Experimental | Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown Receives: Device: Immediate loading of early placed implants; Device: Conventional loading of early placed implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level changes
Marginal bone level changes by standardized periapical radiographs.
Measured: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.
Secondary outcomes (6)
Implant failure rate
defined as implant removal
Measured: 1 year
Implant stability
Osstell readings
Measured: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group)
Midfacial mucosal level
as measured by periodontal probe
Measured: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up
Pink and white esthetic scores
Measured: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up
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: after 6 months and 1 year of placements
Biological, estehtic and technical complications
(infection, implant mobility, or prosthesis-related issues) assessed by expert prosthodontist who is blind to the nature of intervention
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 posted18 Nov 2024
- Study start25 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Collaborators
- Straumann Group, MegaGen
- Responsible party
- Principal investigator, Mohammad AL-Rababáh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693297
- Sponsor's protocol ID
- 10/2024/22294
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 18 Nov 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06693297
- Acronym / sponsor ID
- 10/2024/22294
- Conditions
- Dental Implant
- Keywords
- dental implant, thread design, immediate loading, conventional loading, early placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Collaborators
- Straumann Group, MegaGen
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Nov 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 examining the efficacy and clinical performance of immediate loading of early placed single implants.
The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.
Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.
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, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.
Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional loading of early placed implants | Active comparator | Device: Immediate loading of early placed implants, Device: Conventional loading of early placed implantsEarly placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement ) |
| Immediate loading of early placed implants | Experimental | Device: Immediate loading of early placed implants, Device: Conventional loading of early placed implantsEarly placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or older
- requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)
- having adequate bone volume
- controlled oral hygiene
- having agreed to take part in the study and willing to comply with the study protocol and follow-up visits
Key exclusion criteria (8 listed)
- Any systemic condition that might jeopardize implant surgery
- history of radiation therapy to the head and neck region
- history of bisphosphonate therapy or other medications that may affect bone metabolism
- smoking more than 10 cigarettes/day
- history of bruxism or parafunctional habits
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 |
|---|---|---|
| Immediate loading of early placed implantsImplants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group. | Device | Conventional loading of early placed implants, Immediate loading of early placed implants |
| Conventional loading of early placed implantsDefinitive loading of early placed implants upon successful osteointegration (after 8 weks) | Device | Conventional loading of early placed implants, Immediate loading of early placed implants |
Primary outcome
Marginal bone level changes
Time frame: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.
Marginal bone level changes by standardized periapical radiographs.
6 secondary outcomes
Implant failure rate
Time frame: 1 year
Implant stability
Time frame: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group)
Midfacial mucosal level
Time frame: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up
Pink and white esthetic scores
Time frame: at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up
Patient Satisfaction
Time frame: after 6 months and 1 year of placements
Biological, estehtic and technical complications
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 18 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate loading of early placed implants and Conventional loading of early placed implants 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 5 inclusion and 8 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 18 Nov 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 level changes (time frame: Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), 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 18 Nov 2024.