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Dental ImplantNCT07869030

Melatonin Effect on Immediate Dental Implants in the Posterior Mandible

A study testing 1% w/w Melatonin Gel and Standard Immediate Dental Implant Placement in people with Dental Implant and Immediate Dental Implant Placement, run by Future University in Egypt at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This pilot randomized controlled clinical trial aims to evaluate the feasibility, clinical safety, and preliminary radiographic osteogenic effects of applying topical 1% w/w melatonin gel during immediate implant placement in the posterior mandible. Read more about this study

Who is it for?
Ages 20 to 50 years
What is being tested?
1% w/w Melatonin Gel and Standard Immediate Dental Implant Placement
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
6 Nov 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 20-50 years.
  • Indicated for extraction and immediate implant placement in the posterior mandibular molar region.
  • Good oral hygiene and compliance with postoperative instructions.
  • Non-smokers or light smokers (≤10 cigarettes/day).
  • Patients who provide written informed consent and agree to attend follow-up visits.

Who cannot join

  • Patients with systemic diseases affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis).
  • Heavy smokers (>10 cigarettes/day).
  • History of head and neck radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Sites with acute infection, cystic lesions, or pathology.
  • Bruxism or parafunctional habits.
  • Use of medications affecting bone turnover (e.g., bisphosphonates, corticosteroids).
  • Poor compliance or unwillingness to return for follow-up visits.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine - Future University in Egypt

    Cairo, 43528

    George Waleed Alhajj, B.D.S, +201550820559, georgealhajj1@gmail.com

    George Waleed Alhajj, BDS, MSc Candidate.

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical and Radiographic Assessment of the Osteogenic Effect of Melatonin in Immediate Implant Placement: A Pilot Randomized Clinical Trial.

This pilot randomized controlled clinical trial aims to evaluate the feasibility, clinical safety, and preliminary radiographic osteogenic effects of applying topical 1% w/w melatonin gel during immediate implant placement in the posterior mandible. The study assesses surgical feasibility, soft-tissue healing, bone density, buccal bone thickness, and implant stability to provide preliminary effect size and variance estimates to inform future definitive clinical trials.

Read the detailed description

This study is a pilot randomized controlled clinical trial conducted at Future University in Egypt. Given the technical complexity of immediate implant placement in the posterior mandible combined with customized healing abutments, this pilot study evaluates a sample of 16 participants (8 per group) to assess protocol feasibility, evaluate soft-tissue healing profiles, and estimate outcome variability.

Study Design \& Intervention:

  • Participants: Healthy adults (20-50 years) requiring immediate molar implant placement in the posterior mandible.
  • Test Group: Immediate implant placement with application of 1% w/w topical melatonin gel into the peri-implant socket gap.
  • Control Group: Immediate implant placement using standard surgical protocol without melatonin gel.
  • Socket Management: Both groups utilize a customized healing abutment to seal the socket.

Outcome Assessment:

  • Radiographic Outcomes: Bone density (in Hounsfield Units, HU) and buccal bone thickness (in mm) measured via Cone Beam Computed Tomography (CBCT) at baseline, immediately postoperatively, and at 6 months.
  • Clinical Outcomes: Implant stability measured via AnyCheck (IST values) at placement, 1.5 months, and 3 months.
  • Feasibility \& Safety: Evaluation of post-operative soft-tissue/fascia healing around customized healing abutments and surgical procedure feasibility.
Being tested
1% w/w Melatonin Gel, Standard Immediate Dental Implant Placement
Keywords
Melatonin, Immediate Implant Placement, Osseointegration, AnyCheck, Implant Stability Test, IST, Bone Density, Dental Implants, Alveolar Bone, Posterior Mandible, Buccal Bone Thickness, Pilot Study, Customized Healing Abutment
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1% w/w Melatonin GelDrug

    Topical application of 1% w/w melatonin gel into the peri-implant socket gap immediately prior to dental implant insertion.

  • Standard Immediate Dental Implant PlacementProcedure or surgery

    Standard surgical placement of an immediate dental implant into a fresh extraction socket in the posterior mandible, using a customized healing abutment to seal the socket.

Study groups in NCT07869030
Study groupRoleWhat they receive
Melatonin GroupExperimentalParticipants undergo immediate dental implant placement in the posterior mandible with application of 1% w/w melatonin gel into the extraction socket gap prior to implant insertion, sealed with a customized healing abutment.
Receives: Drug: 1% w/w Melatonin Gel; Procedure: Standard Immediate Dental Implant Placement
Control GroupActive comparatorParticipants undergo immediate dental implant placement in the posterior mandible following standard surgical protocol without melatonin gel application, sealed with a customized healing abutment.
Receives: Procedure: Standard Immediate Dental Implant Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Peri-Implant Bone Density

    Change in peri-implant bone density measured in Hounsfield Units (HU) using Cone Beam Computed Tomography (CBCT) scan cross-sections at the peri-implant defect area.

    Measured: Baseline (immediately post-operatively) and 6 months post-operatively.

  2. Change in Buccal Bone Thickness

    Change in buccal bone plate thickness measured in millimeters (mm) on CBCT cross-sectional views at predefined levels relative to the implant shoulder.

    Measured: Baseline (immediately post-operatively) and 6 months post-operatively.

Secondary outcomes (1)
  1. Change in Primary and Secondary Implant Stability

    Implant stability measured using the AnyCheck device on the Implant Stability Test (IST) scale. IST values range from 30 to 99, where higher values indicate higher implant stability.

    Measured: Baseline (immediately after implant insertion), 1.5 months, and 3 months post-operatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start6 Nov 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Model description
Participants will be randomly allocated into two parallel groups in a 1:1 ratio. Group A (Intervention) will receive an immediate dental implant with the application of 1% w/w melatonin gel into the extraction socket. Group B (Control) will receive an immediate dental implant using the same standard surgical protocol without the application of melatonin gel.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07869030
Sponsor's protocol ID
FUE.REC(107)/12-2025
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) regarding implant stability values (IST as measured by the AnyCheck device) and bone density values (from CBCT analysis) will be shared. Data will be made available to researchers who provide a methodologically sound proposal for secondary analysis. Data access requests should be directed to the principal investigator.

Publications

  • Chen ST, Wilson TG Jr, Hammerle CH. Immediate or early placement of implants following tooth extraction: review of biologic basis, clinical procedures, and outcomes. Int J Oral Maxillofac Implants. 2004;19 Suppl:12-25.

    PubMed 15635942
  • S DS, Kamath D, Sinha A, Kamath D. Melatonin: The potential avenues in dentistry. F1000Res. 2025 Jan 14;14:77. doi: 10.12688/f1000research.159942.1. eCollection 2025.

    PubMed 40125522
  • Hosseinzadeh A, Bagherifard A, Sheibani M, Karimi-Behnagh A, Reiter RJ, Mehrzadi S. Significant Interaction between Melatonin and Titanium Bone Implants: Available Evidence and Future Research Directions. Curr Pharm Biotechnol. 2025;26(9):1258-1270. doi: 10.2174/0113892010300967240610111644.

    PubMed 38919083
  • Ravi Kiran S, Bammidi N, Kumar AK, Kumar PS, Karnam Y. Evaluation of the Effect of Topical Melatonin Application on Immediately Placed Dental Implants Using Cone Beam Computed Tomography (CBCT). Cureus. 2022 May 23;14(5):e25233. doi: 10.7759/cureus.25233. eCollection 2022 May.

    PubMed 35755538
  • El-Gammal MY, Salem AS, Anees MM, Tawfik MA. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial. J Oral Implantol. 2016 Apr;42(2):119-25. doi: 10.1563/aaid-joi-D-14-00277. Epub 2015 Jun 23.

    PubMed 26103559
  • Yan W, Li C, Song X, Zhou W, Chen Z. Prophylactic melatonin for delirium in critically ill patients: A systematic review and meta-analysis with trial sequential analysis. Medicine (Baltimore). 2022 Oct 28;101(43):e31411. doi: 10.1097/MD.0000000000031411.

    PubMed 36316858
  • Zhao Y, Shao G, Liu X, Li Z. Assessment of the Therapeutic Potential of Melatonin for the Treatment of Osteoporosis Through a Narrative Review of Its Signaling and Preclinical and Clinical Studies. Front Pharmacol. 2022 May 11;13:866625. doi: 10.3389/fphar.2022.866625. eCollection 2022.

    PubMed 35645810
  • Huang X, Chen W, Gu C, Liu H, Hou M, Qin W, Zhu X, Chen X, Liu T, Yang H, He F. Melatonin suppresses bone marrow adiposity in ovariectomized rats by rescuing the imbalance between osteogenesis and adipogenesis through SIRT1 activation. J Orthop Translat. 2022 Oct 27;38:84-97. doi: 10.1016/j.jot.2022.10.002. eCollection 2023 Jan.

    PubMed 36381247
  • Maria S, Samsonraj RM, Munmun F, Glas J, Silvestros M, Kotlarczyk MP, Rylands R, Dudakovic A, van Wijnen AJ, Enderby LT, Lassila H, Dodda B, Davis VL, Balk J, Burow M, Bunnell BA, Witt-Enderby PA. Biological effects of melatonin on osteoblast/osteoclast cocultures, bone, and quality of life: Implications of a role for MT2 melatonin receptors, MEK1/2, and MEK5 in melatonin-mediated osteoblastogenesis. J Pineal Res. 2018 Apr;64(3):10.1111/jpi.12465. doi: 10.1111/jpi.12465. Epub 2018 Jan 17.

    PubMed 29285799
  • Vaseenon S, Chattipakorn N, Chattipakorn SC. Effects of melatonin in wound healing of dental pulp and periodontium: Evidence from in vitro, in vivo and clinical studies. Arch Oral Biol. 2021 Mar;123:105037. doi: 10.1016/j.archoralbio.2020.105037. Epub 2021 Jan 6.

    PubMed 33440268
  • Hardeland R, Pandi-Perumal SR. Melatonin, a potent agent in antioxidative defense: actions as a natural food constituent, gastrointestinal factor, drug and prodrug. Nutr Metab (Lond). 2005 Sep 10;2:22. doi: 10.1186/1743-7075-2-22.

    PubMed 16153306
  • Tian Y, Ming J. Melatonin inhibits osteoclastogenesis via RANKL/OPG suppression mediated by Rev-Erbalpha in osteoblasts. J Cell Mol Med. 2022 Jul;26(14):4032-4047. doi: 10.1111/jcmm.17440. Epub 2022 Jun 21.

    PubMed 35726597
  • Hu W, Deng C, Ma Z, Wang D, Fan C, Li T, Di S, Gong B, Reiter RJ, Yang Y. Utilizing melatonin to combat bacterial infections and septic injury. Br J Pharmacol. 2017 May;174(9):754-768. doi: 10.1111/bph.13751. Epub 2017 Mar 21.

    PubMed 28213968
  • Favero G, Franceschetti L, Bonomini F, Rodella LF, Rezzani R. Melatonin as an Anti-Inflammatory Agent Modulating Inflammasome Activation. Int J Endocrinol. 2017;2017:1835195. doi: 10.1155/2017/1835195. Epub 2017 Oct 1.

    PubMed 29104591
  • Cuzzocrea S, Reiter RJ. Pharmacological actions of melatonin in acute and chronic inflammation. Curr Top Med Chem. 2002 Feb;2(2):153-65. doi: 10.2174/1568026023394425.

    PubMed 11899098

Questions about this trial

What is this clinical trial studying?

A study testing 1% w/w Melatonin Gel and Standard Immediate Dental Implant Placement in people with Dental Implant and Immediate Dental Implant Placement, run by Future University in Egypt 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 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Peri-Implant Bone Density (time frame: Baseline (immediately post-operatively) and 6 months post-operatively.). The study lists 2 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 NCT07869030, which also lists 23 linked publications.

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 15 Oct 2026.

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Clinical Trial NCT07869030 | AzTrials