Dental ImplantNCT06528327
Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible
A study testing Pre coated impants and Non coated implant surface in people with Dental Implant and Diabetes Mellitus, Type 2, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Dental Implant, Diabetes Mellitus, Type 2
- What is being tested?
- Pre coated impants and Non coated implant surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jun 2022to 12 Feb 2024
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adequate interproximal space.
- Adequate interocclusal space.
- Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.
- Both genders.
- Controlled medical condition
Who cannot join
- Presence of parafunctional dependency as bruxism.
- Adjacent pathosis near the implant site.
- Patient under radiotherapy targeting the head and neck.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)
Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.
- Conditions
- Dental Implant, Diabetes Mellitus, Type 2
- Being tested
- Pre coated impants, Non coated implant surface
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre coated impantsOther
Pre coated impants with microstructured bioactive antimicrobial coating with double threading for higher bone-to-implant contact and faster bone gathering on the surface.
Non coated implant surfaceOther
Non-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface.
| Study group | Role | What they receive |
|---|---|---|
| Pre coated surface implants | Experimental | Not described Receives: Other: Pre coated impants |
| Non coated surface implants | Active comparator | Not described Receives: Other: Non coated implant surface |
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 assessed using Osstell device
Measured: up to 4 months
change in pain intensity
pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)
Measured: 1st,3rd, and 7th days
Wound Healing score
Landry healing index was used;
- Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present
- Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed
- Good Tissue colour: ≥25% and<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed
- Very good Tissue colour: <25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed
- Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose
Measured: 1st,3rd, and 7th days,14th day
Secondary outcomes (2)
Post operative complications
Occurence of infection was assessed
Measured: 6 months
Change in bone density
CBCT was used to measure bone density
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start26 Jun 2022
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
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
- Single group
- Model description
- Split Mouth Design
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06528327
- Sponsor's protocol ID
- 0375-01/2020
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06528327
- Acronym / sponsor ID
- 0375-01/2020
- Conditions
- Dental Implant, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 30 Jul 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.
Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Pre coated surface implants | Experimental | Other: Pre coated impants |
| Non coated surface implants | Active comparator | Other: Non coated implant surface |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adequate interproximal space.
- Adequate interocclusal space.
- Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.
- Both genders.
- Controlled medical condition
Key exclusion criteria (4 listed)
- Presence of parafunctional dependency as bruxism.
- Adjacent pathosis near the implant site.
- Patient under radiotherapy targeting the head and neck.
- Heavy smokers.
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 |
|---|---|---|
| Pre coated impantsPre coated impants with microstructured bioactive antimicrobial coating with double threading for higher bone-to-implant contact and faster bone gathering on the surface. | Other | Pre coated surface implants |
| Non coated implant surfaceNon-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface. | Other | Non coated surface implants |
Primary outcome
change in implant stability
Time frame: up to 4 months
implant stability will be assessed using Osstell device
change in pain intensity
Time frame: 1st,3rd, and 7th days
pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)
Wound Healing score
Time frame: 1st,3rd, and 7th days,14th day
Landry healing index was used; 1. Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present 2. Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed 3. Good Tissue colour: ≥25% and<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 4. Very good Tissue colour: <25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 5. Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose
2 secondary outcomes
Post operative complications
Time frame: 6 months
Change in bone density
Time frame: up to 4 months
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 30 Jul 2024.
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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 Pre coated impants and Non coated implant surface in people with Dental Implant and Diabetes Mellitus, Type 2, 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 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 30 Jul 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 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: up to 4 months). The study lists 3 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 30 Jul 2024.