Dental ImplantsNCT04521530
Immediate Functional Versus Non Functional Implant Loading in the Mandible
A study testing immediate functional implant loading and immediate non functional implant loading in people with Dental Implants and Edentulous Alveolar Ridge, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT). Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Dental Implants, Edentulous Alveolar Ridge
- What is being tested?
- immediate functional implant loading and immediate non functional implant loading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged (20-40) years old.
- Missing Posterior tooth or teeth indicated for implant placement.
- Residual alveolar ridge at least 10 mm high and at least 4 mm wide.
Who cannot join
- Systemic diseases that will contraindicate the surgery.
- Poor Oral Hygiene.
- The patient refuses to undergo the surgery.
- Parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)
comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).
Read the detailed description
Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.
Implants of the BioInfinity system were placed in 16 subjects divided into two groups.
Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.
Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.
The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.
- Conditions
- Dental Implants, Edentulous Alveolar Ridge
- Being tested
- immediate functional implant loading, immediate non functional implant loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate functional implant loadingOther
Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
immediate non functional implant loadingOther
implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.
| Study group | Role | What they receive |
|---|---|---|
| immediate functional loading with temporary crowns | Experimental | patients were rehabilitated with immediate functionally loaded implants. Receives: Other: immediate functional implant loading |
| immediate non functional loading with temporary crowns | Experimental | patients were rehabilitated with immediate non-functionally loaded implants. Receives: Other: immediate non functional implant loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be
Measured: immediately Postoperatively
Change in crestal bone loss
CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss
Measured: immediately Postoperatively and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Dec 2019
- Primary completion1 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521530
- Sponsor's protocol ID
- Dental implants
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04521530
- Acronym / sponsor ID
- Dental implants
- Conditions
- Dental Implants, Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 20 Aug 2020 (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.
comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).
Detailed description
Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.
Implants of the BioInfinity system were placed in 16 subjects divided into two groups.
Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.
Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.
The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate functional loading with temporary crowns | Experimental | Other: immediate functional implant loadingpatients were rehabilitated with immediate functionally loaded implants. |
| immediate non functional loading with temporary crowns | Experimental | Other: immediate non functional implant loadingpatients were rehabilitated with immediate non-functionally loaded implants. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged (20-40) years old.
- Missing Posterior tooth or teeth indicated for implant placement.
- Residual alveolar ridge at least 10 mm high and at least 4 mm wide.
Key exclusion criteria (4 listed)
- Systemic diseases that will contraindicate the surgery.
- Poor Oral Hygiene.
- The patient refuses to undergo the surgery.
- 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 functional implant loadingPatients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented. | Other | immediate functional loading with temporary crowns |
| immediate non functional implant loadingimplant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented. | Other | immediate non functional loading with temporary crowns |
Primary outcome
Pain score
Time frame: immediately Postoperatively
Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be
Change in crestal bone loss
Time frame: immediately Postoperatively and after 4 months
CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 functional implant loading and immediate non functional implant loading in people with Dental Implants and Edentulous Alveolar Ridge, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 20 Aug 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: immediately Postoperatively). The study lists 2 primary outcomes in all. 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 20 Aug 2020.