Edentulous; Alveolar Process, AtrophyNCT04625179
Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
A study testing Melatonin and hyaluronic acid and sinus membrane elevation and sinus membrane elevation without any materials in people with Edentulous; Alveolar Process, Atrophy, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties. the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy
- What is being tested?
- Melatonin and hyaluronic acid and sinus membrane elevation and sinus membrane elevation without any materials
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2019to 7 Dec 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range will be between (30 - 50) years old.
- Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
- Adequate inter-occlusal space of at least 8 mm
Who cannot join
- Maxillary sinus diseases.
- Previous sinus surgery like the Caldwell-Luc operation.
- History of chemotherapy or radiotherapy to maxilla.
- Presence of Underwood's septa/severe sinus floor convolutions.
- Systemic disease affecting bone metabolism.
- Uncontrolled diabetes mellitus.
- Heavy smokers.
- Para functional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties.
the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated
Read the detailed description
16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.
The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Being tested
- Melatonin and hyaluronic acid and sinus membrane elevation, sinus membrane elevation without any materials
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin and hyaluronic acid and sinus membrane elevationOther
3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
sinus membrane elevation without any materialsProcedure or surgery
No materials will be placed at the sinus space.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin and hyaluronic acid and sinus membrane elevation | Experimental | melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement Receives: Other: Melatonin and hyaluronic acid and sinus membrane elevation |
| sinus membrane elevation without any materials | Active comparator | no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants. Receives: Procedure: sinus membrane elevation without any materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
change Implant stability
The result is presented as an ISQ value of 1-100. The acceptable stability range lies between 55-85 ISQ. The higher the ISQ, the more stable the implant
Measured: at baseline and 6 months
change in bone density
radiographical evaluation using CBCT
Measured: at baseline, 1 month and 6 months
change in vertical bone height
radiographical evaluation using CBCT
Measured: at baseline, 1 month and 6 months
change in marginal bone level
radiographical evaluation using CBCT
Measured: at baseline, 1 month and 6 months
Secondary outcomes (2)
Postoperative pain
based on a 4-point verbal descriptive scale as following: no pain, mild (recognizable but not discomforting pain that required no analgesics), moderate (discomforting but bearable pain and analgesics if used were effective in relieving pain) and severe (difficult to bear and analgesics were effective in relieving pain).
Measured: after 1 week
Postoperative swelling
none (no inflammation), mild (intraoral swelling confined to the surgical field), moderate (extraoral swelling in the surgical zone) and severe (extraoral swelling spreading beyond the surgical zone).
Measured: after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start3 Dec 2019
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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
- NCT04625179
- Sponsor's protocol ID
- Maxillary sinus augmentation
- Status last verified
- Dec 2020
- First submitted
- 6 Nov 2020
- Last updated
- 17 Dec 2020
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04625179
- Acronym / sponsor ID
- Maxillary sinus augmentation
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 12 Nov 2020 (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.
melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties.
the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated
Detailed description
16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.
The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin and hyaluronic acid and sinus membrane elevation | Experimental | Other: Melatonin and hyaluronic acid and sinus membrane elevationmelatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement |
| sinus membrane elevation without any materials | Active comparator | Procedure: sinus membrane elevation without any materialsno materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range will be between (30 - 50) years old.
- Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
- Adequate inter-occlusal space of at least 8 mm
Key exclusion criteria (8 listed)
- Maxillary sinus diseases.
- Previous sinus surgery like the Caldwell-Luc operation.
- History of chemotherapy or radiotherapy to maxilla.
- Presence of Underwood's septa/severe sinus floor convolutions.
- Systemic disease affecting bone metabolism.
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 |
|---|---|---|
| Melatonin and hyaluronic acid and sinus membrane elevation3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex. | Other | Melatonin and hyaluronic acid and sinus membrane elevation |
| sinus membrane elevation without any materialsNo materials will be placed at the sinus space. | Procedure or surgery | sinus membrane elevation without any materials |
Primary outcome
change Implant stability
Time frame: at baseline and 6 months
The result is presented as an ISQ value of 1-100. The acceptable stability range lies between 55-85 ISQ. The higher the ISQ, the more stable the implant
change in bone density
Time frame: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
change in vertical bone height
Time frame: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
change in marginal bone level
Time frame: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
2 secondary outcomes
Postoperative pain
Time frame: after 1 week
Postoperative swelling
Time frame: after 1 week
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 17 Dec 2020.
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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 Melatonin and hyaluronic acid and sinus membrane elevation and sinus membrane elevation without any materials in people with Edentulous; Alveolar Process, Atrophy, 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 3 inclusion and 8 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 17 Dec 2020. 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 Implant stability (time frame: at baseline and 6 months). The study lists 4 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 17 Dec 2020.