Dental ImplantsNCT07103564
The Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolar
A study testing Immediately placed implant in maxillary premolars with local melatonin application and Immediately placed implant in maxillary premolars without local melatonin application in people with Dental Implants and Osteoprotegerin, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Immediate implants provide ideal three-dimensional positioning compared to conventional implants. There may be a gap between the surface of the implant and the bone walls of the socket when it is inserted into a recently extracted alveolus. To compensate for this, various grafting materials are used. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Dental Implants, Osteoprotegerin, Melatonin
- What is being tested?
- Immediately placed implant in maxillary premolars with local melatonin application and Immediately placed implant in maxillary premolars without local melatonin application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 15 Jul 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with non-restorable maxillary premolars with sufficient bone quantity to receive the dental implant without the need for bone graft.
- Patients with no local or systemic pathology that can interfere with normal wound healing.
- Non-smokers.
- Patients who are properly motivated to complete follow-up visits
Who cannot join
- Patients with uncontrolled medical conditions that can affect surgical outcome or bone and wound healing. (ex: uncontrolled diabetes mellitus)
- Patients with periapical pathology that may contraindicate immediate implant placement.
- History of receiving irradiation in the head and neck region
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: The Evaluation of the Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolars (Randomized Controlled Clinical Trial)
Background: Immediate implants provide ideal three-dimensional positioning compared to conventional implants. There may be a gap between the surface of the implant and the bone walls of the socket when it is inserted into a recently extracted alveolus. To compensate for this, various grafting materials are used. Recently, melatonin has gained significant attention because of its inhibitory action on bone resorption through upregulating the expression of osteoprotegerin, which acts as a decoy receptor for RANKL and inhibits its binding to osteoclast precursors thereby inhibiting osteoclast formation and activity. So, we will conduct this study to evaluate the effects of local melatonin application around immediately placed implants.
Aim of the study: To evaluate the effectiveness of adding local melatonin around immediately placed implants in maxillary premolars.
- Conditions
- Dental Implants, Osteoprotegerin, Melatonin
- Being tested
- Immediately placed implant in maxillary premolars with local melatonin application, Immediately placed implant in maxillary premolars without local melatonin application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediately placed implant in maxillary premolars with local melatonin applicationOther
Patients will receive immediately placed implants with local melatonin powder (3mg) application.
Immediately placed implant in maxillary premolars without local melatonin applicationOther
Patients will receive immediately placed implants without local melatonin application.
| Study group | Role | What they receive |
|---|---|---|
| melatonin therapy | Experimental | Not described Receives: Other: Immediately placed implant in maxillary premolars with local melatonin application |
| No melatonin | Active comparator | Not described Receives: Other: Immediately placed implant in maxillary premolars without local melatonin application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Osteoprotegerin
OPG (Ng/ml) level will be measured preoperatively, 1 and 3 months post operatively, to evaluate the bone healing activity. The level will be evaluated by collecting 5 ml of peripheral blood in blank tubes and will be allowed for complete clotting and will be centrifuged at 1000 g for 15 min. The separated serum will be then stored at -20 0C.
Measured: Baseline, 1 month, and 3 months
Change in bone volume
CBCT scans will be obtained to measure change in bone volume
Measured: Baseline and 6 months
Change in bone level
CBCT scans will be obtained to measure change in bone level
Measured: Baseline and 6 months
Change in bone density
CBCT scans will be obtained to measure change in bone density
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jul 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- 24 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
- NCT07103564
- Sponsor's protocol ID
- 0812-12/2023
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helal TM, Saleh MM, Metawie DMN. Effect of local melatonin application on immediately placed implants in maxillary premolars (a biochemical and radiographic randomized controlled clinical trial). BMC Oral Health. 2026 Oct 17;26(1):2040. doi: 10.1186/s12903-026-09968-y.
PubMed 42892692
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Local Melatonin Application Around Immediately Placed Implants in the Maxillary Premolars (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07103564
- Acronym / sponsor ID
- 0812-12/2023
- Conditions
- Dental Implants, Osteoprotegerin, Melatonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 5 Aug 2025 (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.
Background: Immediate implants provide ideal three-dimensional positioning compared to conventional implants. There may be a gap between the surface of the implant and the bone walls of the socket when it is inserted into a recently extracted alveolus. To compensate for this, various grafting materials are used. Recently, melatonin has gained significant attention because of its inhibitory action on bone resorption through upregulating the expression of osteoprotegerin, which acts as a decoy receptor for RANKL and inhibits its binding to osteoclast precursors thereby inhibiting osteoclast formation and activity. So, we will conduct this study to evaluate the effects of local melatonin application around immediately placed implants.
Aim of the study: To evaluate the effectiveness of adding local melatonin around immediately placed implants in maxillary premolars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin therapy | Experimental | Other: Immediately placed implant in maxillary premolars with local melatonin application |
| No melatonin | Active comparator | Other: Immediately placed implant in maxillary premolars without local melatonin application |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with non-restorable maxillary premolars with sufficient bone quantity to receive the dental implant without the need for bone graft.
- Patients with no local or systemic pathology that can interfere with normal wound healing.
- Non-smokers.
- Patients who are properly motivated to complete follow-up visits
Key exclusion criteria (3 listed)
- Patients with uncontrolled medical conditions that can affect surgical outcome or bone and wound healing. (ex: uncontrolled diabetes mellitus)
- Patients with periapical pathology that may contraindicate immediate implant placement.
- History of receiving irradiation in the head and neck region
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 |
|---|---|---|
| Immediately placed implant in maxillary premolars with local melatonin applicationPatients will receive immediately placed implants with local melatonin powder (3mg) application. | Other | melatonin therapy |
| Immediately placed implant in maxillary premolars without local melatonin applicationPatients will receive immediately placed implants without local melatonin application. | Other | No melatonin |
Primary outcome
Change in Osteoprotegerin
Time frame: Baseline, 1 month, and 3 months
OPG (Ng/ml) level will be measured preoperatively, 1 and 3 months post operatively, to evaluate the bone healing activity. The level will be evaluated by collecting 5 ml of peripheral blood in blank tubes and will be allowed for complete clotting and will be centrifuged at 1000 g for 15 min. The separated serum will be then stored at -20 0C.
Change in bone volume
Time frame: Baseline and 6 months
CBCT scans will be obtained to measure change in bone volume
Change in bone level
Time frame: Baseline and 6 months
CBCT scans will be obtained to measure change in bone level
Change in bone density
Time frame: Baseline and 6 months
CBCT scans will be obtained to measure change in bone density
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 5 Aug 2025.
- Derived from this study: PubMed 42892692Helal TM, Saleh MM, Metawie DMN. Effect of local melatonin application on immediately placed implants in maxillary premolars (a biochemical and radiographic randomized controlled clinical trial). BMC Oral Health. 2026 Oct 17;26(1):2040. doi: 10.1186/s12903-026-09968-y.
Related trials for Dental Implants
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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 Immediately placed implant in maxillary premolars with local melatonin application and Immediately placed implant in maxillary premolars without local melatonin application in people with Dental Implants and Osteoprotegerin, 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 4 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 5 Aug 2025. 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 Osteoprotegerin (time frame: Baseline, 1 month, and 3 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?
On the ClinicalTrials.gov record for NCT07103564, which also lists 1 linked publication.
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 5 Aug 2025.