Patients With Missing TeethPhase 2NCT05593731
Platelet Rich Fibrin Versus Melatonin Around Dental Implants
A Phase 2 study testing dental implants with melatonin gel in people with Patients With Missing Teeth, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patients With Missing Teeth
- What is being tested?
- dental implants with melatonin gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2021to 10 Aug 2022
- Phase
- Phase 2
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good oral hygiene participants,
- free of any systemic diseases,
- Patients' age ranged from 20 to 40 years old.
- Patients who can complete surgery and the study protocol.
- Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health.
Who cannot join
- patients who had parafunctional habits,
- current and former smokers, pregnant
- lactating women
- unmotivated patients
- patients with psychological problems
- patients who were not able to follow the treatment protocol -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial
Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.
- Conditions
- Patients With Missing Teeth
- Being tested
- dental implants with melatonin gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implants with melatonin gelBiological
Also called dental implants with platelet rich fibrin
platelet rich fibrin membrane around dental implants
| Study group | Role | What they receive |
|---|---|---|
| dental implants alone | Other | dental implants alone Receives: Biological: dental implants with melatonin gel |
| platelet rich fibrin | Active comparator | dental implants with platelet rich fibrin membrane Receives: Biological: dental implants with melatonin gel |
| melatonin gel | Active comparator | dental implants with melatonin gel around dental implants Receives: Biological: dental implants with melatonin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival thickness
Measured: 6 months
Secondary outcomes (2)
bone density
Measured: 6 months
marginal bone loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start10 Dec 2021
- Primary completion10 Jul 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Missing TeethStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Elsherif, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593731
- Sponsor's protocol ID
- Misprotocol
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Delivered Platelet Rich Fibrin Versus Melatonin Gel on the Osseointegration of Dental Implant. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05593731
- Acronym / sponsor ID
- Misprotocol
- Conditions
- Patients With Missing Teeth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 25 Oct 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.
Dental implant is a dental treatment that allow oral rehabilitation for partial and fully edentulous patients. Osteointegration is the factor that control success s or failure of dental implant that can be improved by addition of different adjunctive biological materials. Platelets Rich fibrin plays a significant role in tissue regeneration and wound healing. Melatonin is biological hormone that secreted from pineal gland and played an important role in human growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dental implants alone | Other | Biological: dental implants with melatonin geldental implants alone |
| platelet rich fibrin | Active comparator | Biological: dental implants with melatonin geldental implants with platelet rich fibrin membrane |
| melatonin gel | Active comparator | Biological: dental implants with melatonin geldental implants with melatonin gel around dental implants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- good oral hygiene participants,
- free of any systemic diseases,
- Patients' age ranged from 20 to 40 years old.
- Patients who can complete surgery and the study protocol.
- Partially edentulous patients in the posterior mandibular region (at least a single-mandibular edentulous area) with periodontal health.
Key exclusion criteria (6 listed)
- patients who had parafunctional habits,
- current and former smokers, pregnant
- lactating women
- unmotivated patients
- patients with psychological problems
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 |
|---|---|---|
| dental implants with melatonin gelAlso: dental implants with platelet rich fibrinplatelet rich fibrin membrane around dental implants | Biological | dental implants alone, melatonin gel, platelet rich fibrin |
Primary outcome
gingival thickness
Time frame: 6 months
2 secondary outcomes
bone density
Time frame: 6 months
marginal bone loss
Time frame: 6 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 23 Oct 2023.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing dental implants with melatonin gel in people with Patients With Missing Teeth, run by Misr University for Science and Technology 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 6 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 23 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
gingival thickness (time frame: 6 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 23 Oct 2023.