Dental ImplantNCT05125445
Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients
A study testing Implants placed at bone crest and Implants placed 1mm Subcrestally in people with Dental Implant and Diabetes, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Dental Implant, Diabetes
- What is being tested?
- Implants placed at bone crest and Implants placed 1mm Subcrestally
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2021to 23 Aug 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 controlled diabetic patients
- Patients with at least one missing tooth in lower jaw.
- Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
- Patients with sufficient inter-occlusal distance that will allow future restoration.
- Patients with healthy periodontium.
Who cannot join
- Smokers.
- Para functional habits.
- Bad oral hygiene measured according to O'Leary plaque index.
- Pregnant women.
- Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)
The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography
- Conditions
- Dental Implant, Diabetes
- Being tested
- Implants placed at bone crest, Implants placed 1mm Subcrestally
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implants placed at bone crestProcedure or surgery
Mid crestal incision will be performed and full-thickness envelope flap will be elevated to expose the alveolar ridge (no releasing incisions will be made).
Implant site will be prepared according to the manufacturer's instructions under sterile copious irrigation Implants will be placed at crestal level
Implants placed 1mm SubcrestallyProcedure or surgery
Implants will be placed 1mm subcrestally
| Study group | Role | What they receive |
|---|---|---|
| Crestally positioned implants | Experimental | Not described Receives: Procedure: Implants placed at bone crest |
| Subcrestally positioned implants | Active comparator | Not described Receives: Procedure: Implants placed 1mm Subcrestally |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Implant stability
Implant stability will be measured again by Osstell at 3 different directions (buccal, mesial and distal) at the time of implant loading (after 3 months from implant placement).
Measured: at baseline and 3 months
change in margianl bone level
CBCT will be done Marginal bone loss in all aspects (mesial, distal buccal and lingual) The difference in distance from bone crest to apical end of the implant will be assessed at each follow up period then the mean will be calculated for mesial and distal and also for buccal and lingual.
Measured: at baseline, 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start11 Feb 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
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
- None (open label)
- Enrolment
- 22 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
- NCT05125445
- Sponsor's protocol ID
- Implants_diabetes
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2021
- Last updated
- 18 Nov 2021
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05125445
- Acronym / sponsor ID
- Implants_diabetes
- Conditions
- Dental Implant, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 18 Nov 2021 (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 objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crestally positioned implants | Experimental | Procedure: Implants placed at bone crest |
| Subcrestally positioned implants | Active comparator | Procedure: Implants placed 1mm Subcrestally |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 controlled diabetic patients
- Patients with at least one missing tooth in lower jaw.
- Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
- Patients with sufficient inter-occlusal distance that will allow future restoration.
- Patients with healthy periodontium.
Key exclusion criteria (5 listed)
- Smokers.
- Para functional habits.
- Bad oral hygiene measured according to O'Leary plaque index.
- Pregnant women.
- Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.
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 |
|---|---|---|
| Implants placed at bone crestMid crestal incision will be performed and full-thickness envelope flap will be elevated to expose the alveolar ridge (no releasing incisions will be made). Implant site will be prepared according to the manufacturer's instructions under sterile copious irrigation Implants will be placed at crestal level | Procedure or surgery | Crestally positioned implants |
| Implants placed 1mm SubcrestallyImplants will be placed 1mm subcrestally | Procedure or surgery | Subcrestally positioned implants |
Primary outcome
change in Implant stability
Time frame: at baseline and 3 months
Implant stability will be measured again by Osstell at 3 different directions (buccal, mesial and distal) at the time of implant loading (after 3 months from implant placement).
change in margianl bone level
Time frame: at baseline, 3rd and 6th months
CBCT will be done Marginal bone loss in all aspects (mesial, distal buccal and lingual) The difference in distance from bone crest to apical end of the implant will be assessed at each follow up period then the mean will be calculated for mesial and distal and also for buccal and lingual.
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 18 Nov 2021.
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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 Implants placed at bone crest and Implants placed 1mm Subcrestally in people with Dental Implant and Diabetes, 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 5 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 18 Nov 2021. 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 Implant stability (time frame: at baseline and 3 months). 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 18 Nov 2021.