Dental ImplantsNCT06034132
Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid
A study testing Stock healing abutments and Compoiste healing abutments in people with Dental Implants, run by Alexandria University at 1 site in Egypt.
Trial summary
Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Stock healing abutments and Compoiste healing abutments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Jun 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with no systemic and/or oral health disease
- absence of any lesions in the oral cavity
- wide band of keratinized tissue more than 1mm at implant site
Who cannot join
- smoking more than 20 cigarettes per day
- localized radiation therapy of the oral cavity,
- antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)
Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid
- Conditions
- Dental Implants
- Being tested
- Stock healing abutments, Compoiste healing abutments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stock healing abutmentsOther
2ND stage surgery will be performed and stock healing abutment were placed
Compoiste healing abutmentsOther
2ND stage surgery will be performed and composite healing abutment were placed
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Compoiste healing abutments |
| Control group | Active comparator | Not described Receives: Other: Stock healing abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MMP8 levels
Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit
Measured: at 2 weeks and 4 weeks
Secondary outcomes (3)
Change in gingival condition
Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation
- = mild inflammation
- = mild inflammation
- = moderate inflmmation
- = severe inflammation
Measured: at 2 weeks and 4 weeks
Change in gingival bleeding
Bleeding index will be recorded as present or absent
Measured: at 2 weeks and 4 weeks
Change in plaque accumulation
Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
Measured: at 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034132
- Sponsor's protocol ID
- Implants_2022_MP8
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)
- ClinicalTrials.gov ID
- NCT06034132
- Acronym / sponsor ID
- Implants_2022_MP8
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 13 Sep 2023 (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.
Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Compoiste healing abutments |
| Control group | Active comparator | Other: Stock healing abutments |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with no systemic and/or oral health disease
- absence of any lesions in the oral cavity
- wide band of keratinized tissue more than 1mm at implant site
Key exclusion criteria (3 listed)
- smoking more than 20 cigarettes per day
- localized radiation therapy of the oral cavity,
- antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity
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 |
|---|---|---|
| Stock healing abutments2ND stage surgery will be performed and stock healing abutment were placed | Other | Control group |
| Compoiste healing abutments2ND stage surgery will be performed and composite healing abutment were placed | Other | Test group |
Primary outcome
Change in MMP8 levels
Time frame: at 2 weeks and 4 weeks
Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit
3 secondary outcomes
Change in gingival condition
Time frame: at 2 weeks and 4 weeks
Change in gingival bleeding
Time frame: at 2 weeks and 4 weeks
Change in plaque accumulation
Time frame: at 2 weeks and 4 weeks
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 13 Sep 2023.
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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 Stock healing abutments and Compoiste healing abutments in people with Dental Implants, run by Alexandria University 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 3 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 13 Sep 2023. 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 MMP8 levels (time frame: at 2 weeks and 4 weeks). 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 13 Sep 2023.