Bone LossNCT05620797
Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture
A study testing Immediate loading of the implants and Delayed loading of the implant in people with Bone Loss and Dental Implant, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Bone Loss, Dental Implant
- What is being tested?
- Immediate loading of the implants and Delayed loading of the implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 30 Jun 2021
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having two standing mandibular canines with compromised prognosis (which indicted for extraction, without any preapical lesions nor acute infection) and have an adequate labial bone thickness.
- Patient having opposing completely edenteolous maxilla.
- Patients having normal maxilla-mandibular relationship and sufficient inter arch distance was insured by through tentative jaw relation record.
- Patients with good oral hygiene.
- Enough bone volume for implants in the interforaminal region (adequate bone quality and quantity)
Who cannot join
- Mental disorder patients who are not capable of making a decision or narcotic drug addicts.
- Patients with Tempro-Mandibular Joint disorders
- Patients undergoing radiotherapy or chemotherapy
- Patients with systemic diseases affecting bone metabolism
- Uncooperative patients who have no understanding of the need of a regular follow-up.
- Patient with pathological defects in the areas of implant insertion.
- Vulnerable group as prisoners, mentally retarded patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Versus Delayed Loading for Immediately Inserted Implants Retaining Mandibular Complete Overdenture
The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture.
- Conditions
- Bone Loss, Dental Implant
- Being tested
- Immediate loading of the implants, Delayed loading of the implant
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loading of the implantsOther
Patients of this group will be rehabilitated by implant-retained mandibular overdenture with immediate loading of the implants as opposed to conventional maxillary complete dentures.
Delayed loading of the implantOther
Patients of this group will be rehabilitated by implant retained mandibular overdenture with delayed loading of the implants (after 3 months) opposed by conventional maxillary complete dentures
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading implants | Experimental | Not described Receives: Other: Immediate loading of the implants |
| Delayed loading implants | Active comparator | Not described Receives: Other: Delayed loading of the implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone loss
Every 3 months all patients were recalled for assessment of marginal bone loss. The assessment was done using digital periapical radiograph Ezsensor (Vatech intraoral radiographic sensor, Vatech, South Korea) and the technique of radiograph was paralleling technique using sensor holder (TROLLBYTE PLUS, TROLLDENTAL, UK) to ensure same position of cone through subsequent follow-up exposures
Measured: at 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Mar 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- 14 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
- NCT05620797
- Sponsor's protocol ID
- implant_86_2018
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Loading for Immediately Inserted Implants Retaining Mandibular Complete Overdenture
- ClinicalTrials.gov ID
- NCT05620797
- Acronym / sponsor ID
- implant_86_2018
- Conditions
- Bone Loss, Dental Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Nov 2022 (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.
The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading implants | Experimental | Other: Immediate loading of the implants |
| Delayed loading implants | Active comparator | Other: Delayed loading of the implant |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient having two standing mandibular canines with compromised prognosis (which indicted for extraction, without any preapical lesions nor acute infection) and have an adequate labial bone thickness.
- Patient having opposing completely edenteolous maxilla.
- Patients having normal maxilla-mandibular relationship and sufficient inter arch distance was insured by through tentative jaw relation record.
- Patients with good oral hygiene.
- Enough bone volume for implants in the interforaminal region (adequate bone quality and quantity)
Key exclusion criteria (7 listed)
- Mental disorder patients who are not capable of making a decision or narcotic drug addicts.
- Patients with Tempro-Mandibular Joint disorders
- Patients undergoing radiotherapy or chemotherapy
- Patients with systemic diseases affecting bone metabolism
- Uncooperative patients who have no understanding of the need of a regular follow-up.
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 the implantsPatients of this group will be rehabilitated by implant-retained mandibular overdenture with immediate loading of the implants as opposed to conventional maxillary complete dentures. | Other | Immediate loading implants |
| Delayed loading of the implantPatients of this group will be rehabilitated by implant retained mandibular overdenture with delayed loading of the implants (after 3 months) opposed by conventional maxillary complete dentures | Other | Delayed loading implants |
Primary outcome
Change in bone loss
Time frame: at 3 months, 6 months, 9 months, 12 months
Every 3 months all patients were recalled for assessment of marginal bone loss. The assessment was done using digital periapical radiograph Ezsensor (Vatech intraoral radiographic sensor, Vatech, South Korea) and the technique of radiograph was paralleling technique using sensor holder (TROLLBYTE PLUS, TROLLDENTAL, UK) to ensure same position of cone through subsequent follow-up exposures
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 14 Dec 2022.
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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 loading of the implants and Delayed loading of the implant in people with Bone Loss and Dental Implant, 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 5 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: finished, as of the sponsor's last update on 14 Dec 2022. 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?
Change in bone loss (time frame: at 3 months, 6 months, 9 months, 12 months). 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 14 Dec 2022.