Chronic Apical PeriodontitisNCT07829393
Topical Melatonin for Immediate Implants in Chronically Infected Extraction Sockets
A study testing Topical Melatonin in people with Chronic Apical Periodontitis and Dental Implantation, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of topical 2% melatonin gel on implant stability and osseointegration of immediate implants placed in chronically infected extraction sockets. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Apical Periodontitis, Dental Implantation, Infected Extraction Socket
- What is being tested?
- Topical Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to 25 Jul 2026
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-50 years.
- Non-restorable teeth associated with chronic apical lesions persisting after previous endodontic treatment and/or periapical surgery.
- Adequate interarch relationship and interocclusal space for prosthetic rehabilitation.
- Expected peri-implant jumping gap ≥2 mm.
- Good oral hygiene and willingness to comply with follow-up visits.
- The chronic periapical lesion of a predefined radiographic size range of [4 - 10 mm], measured as the maximum lesion diameter on preoperative CBCT.
Who cannot join
- Smokers.
- Alcohol or drug abuse.
- Pregnancy.
- Systemic conditions contraindicating implant placement.
- Bruxism or other parafunctional habits.
- Inability or unwillingness to maintain oral hygiene or attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Melatonin on Osseointegration of Immediate Implants Placed in Chronically Infected Extraction Sockets: A Randomized Controlled Clinical Trial
The purpose of this study is to evaluate the effect of topical 2% melatonin gel on implant stability and osseointegration of immediate implants placed in chronically infected extraction sockets. Sixty patients requiring extraction of non-restorable teeth associated with chronic apical lesions will be randomly assigned to receive either conventional immediate implant placement with bone graft only or immediate implant placement with adjunctive topical melatonin. Implant stability will be assessed using resonance frequency analysis over a 12-month follow-up period. Secondary outcomes will include marginal bone loss, peri-implant bone density, postoperative pain, soft tissue healing, postoperative infection, and implant survival.
Read the detailed description
Immediate implant placement has become a predictable treatment modality that shortens treatment time and helps preserve alveolar bone architecture. Although successful outcomes have been reported in chronically infected extraction sockets following meticulous debridement and infection control, the inflammatory environment may adversely affect early bone healing and osseointegration.
Melatonin (N-acetyl-5-methoxytryptamine) exhibits antioxidant, anti-inflammatory, antimicrobial, and osteogenic properties that may enhance peri-implant bone regeneration. Previous studies have suggested that topical melatonin can stimulate osteoblastic activity, increase bone formation, and improve implant stability. However, evidence regarding its effectiveness in immediate implant placement within chronically infected extraction sockets remains limited.
This study is designed as a quadruple-blinded, parallel-arm randomized controlled clinical trial involving 60 participants. Following atraumatic extraction, thorough socket debridement, immediate implant placement, and grafting of the peri-implant jumping gap, participants will be allocated to one of two treatment groups. In the experimental group, a sterile 2% melatonin gel will be applied to the implant surface and mixed with the grafting material before placement. Clinical and radiographic outcomes will be evaluated for 12 months following implant placement.
- Being tested
- Topical Melatonin, Control
- Keywords
- melatonin;, osseointegration;, immediate implants;, infected sockets;, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical MelatoninDrug
Participants will undergo immediate implant placement in chronically infected extraction sockets. A sterile 2% melatonin gel will be applied to the implant surface immediately before implant insertion and mixed with Si-β-TCP putty bone substitute prior to grafting of the peri-implant jumping gap.
Intervention: Topical Melatonin Gel 2%
ControlOther
Participants will undergo immediate implant placement in chronically infected extraction sockets followed by grafting of the peri-implant jumping gap with Si-β-TCP putty bone substitute alone.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Experimental | Local application of sterile 2% melatonin gel to the implant surface and mixed with Si-β-TCP putty bone substitute graft material placed in the peri-implant jumping gap after immediate implant placement. Receives: Drug: Topical Melatonin |
| control group | Active comparator | Description: Immediate implant placement with Si-β-TCP putty bone substitute placement in the peri-implant jumping gap without melatonin application. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
Implant stability will be assessed using resonance frequency analysis (Osstell Mentor device). The mean value of four measurements obtained around each implant will be recorded.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months after implant placement.
Secondary outcomes (6)
Marginal Bone Loss
Marginal bone loss will be assessed using CBCT imaging by comparing crestal bone levels around implants.
Measured: Baseline and 6 months.
Relative Peri-implant Bone Density
Relative peri-implant bone density will be evaluated using CBCT gray-value analysis.
Measured: 6 months.
Postoperative Pain
Pain intensity will be evaluated using an 11-point Numeric Rating Scale (0-10).
Measured: Postoperative days 1, 3, and 7.
Soft Tissue Healing
Soft tissue healing will be evaluated using the Landry Wound Healing Index.
Measured: 7 and 14 days postoperatively.
Implant Survival
Implant survival will be defined as the implant remaining in situ and functional without mobility or removal.
Measured: 12 months after implant placement.
Postoperative Infection
Presence or absence of infection will be assessed clinically.
Measured: 7 days, 14 days, and 4 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start3 Jan 2023
- Primary completion15 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical PeriodontitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna hosny, Mansoura University
- Investigators
- Faculty of Dentistry Mansoura University Mansoura,, Egypt, Principal investigator, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829393
- Sponsor's protocol ID
- DU025012601
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Melatonin on Osseointegration of Immediate Implants Placed in Chronically Infected Extraction Sockets: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07829393
- Acronym / sponsor ID
- DU025012601
- Keywords
- melatonin;, osseointegration;, immediate implants;, infected sockets;, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 21 Sep 2026 (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.
The purpose of this study is to evaluate the effect of topical 2% melatonin gel on implant stability and osseointegration of immediate implants placed in chronically infected extraction sockets. Sixty patients requiring extraction of non-restorable teeth associated with chronic apical lesions will be randomly assigned to receive either conventional immediate implant placement with bone graft only or immediate implant placement with adjunctive topical melatonin. Implant stability will be assessed using resonance frequency analysis over a 12-month follow-up period. Secondary outcomes will include marginal bone loss, peri-implant bone density, postoperative pain, soft tissue healing, postoperative infection, and implant survival.
Detailed description
Immediate implant placement has become a predictable treatment modality that shortens treatment time and helps preserve alveolar bone architecture. Although successful outcomes have been reported in chronically infected extraction sockets following meticulous debridement and infection control, the inflammatory environment may adversely affect early bone healing and osseointegration.
Melatonin (N-acetyl-5-methoxytryptamine) exhibits antioxidant, anti-inflammatory, antimicrobial, and osteogenic properties that may enhance peri-implant bone regeneration. Previous studies have suggested that topical melatonin can stimulate osteoblastic activity, increase bone formation, and improve implant stability. However, evidence regarding its effectiveness in immediate implant placement within chronically infected extraction sockets remains limited.
This study is designed as a quadruple-blinded, parallel-arm randomized controlled clinical trial involving 60 participants. Following atraumatic extraction, thorough socket debridement, immediate implant placement, and grafting of the peri-implant jumping gap, participants will be allocated to one of two treatment groups. In the experimental group, a sterile 2% melatonin gel will be applied to the implant surface and mixed with the grafting material before placement. Clinical and radiographic outcomes will be evaluated for 12 months following implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin Group | Experimental | Drug: Topical MelatoninLocal application of sterile 2% melatonin gel to the implant surface and mixed with Si-β-TCP putty bone substitute graft material placed in the peri-implant jumping gap after immediate implant placement. |
| control group | Active comparator | Other: ControlDescription: Immediate implant placement with Si-β-TCP putty bone substitute placement in the peri-implant jumping gap without melatonin application. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-50 years.
- Non-restorable teeth associated with chronic apical lesions persisting after previous endodontic treatment and/or periapical surgery.
- Adequate interarch relationship and interocclusal space for prosthetic rehabilitation.
- Expected peri-implant jumping gap ≥2 mm.
- Good oral hygiene and willingness to comply with follow-up visits.
Key exclusion criteria (6 listed)
- Smokers.
- Alcohol or drug abuse.
- Pregnancy.
- Systemic conditions contraindicating implant placement.
- Bruxism or other parafunctional habits.
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 |
|---|---|---|
| Topical MelatoninParticipants will undergo immediate implant placement in chronically infected extraction sockets. A sterile 2% melatonin gel will be applied to the implant surface immediately before implant insertion and mixed with Si-β-TCP putty bone substitute prior to grafting of the peri-implant jumping gap. Intervention: Topical Melatonin Gel 2% | Drug | Melatonin Group |
| ControlParticipants will undergo immediate implant placement in chronically infected extraction sockets followed by grafting of the peri-implant jumping gap with Si-β-TCP putty bone substitute alone. | Other | control group |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months after implant placement.
Implant stability will be assessed using resonance frequency analysis (Osstell Mentor device). The mean value of four measurements obtained around each implant will be recorded.
6 secondary outcomes
Marginal Bone Loss
Time frame: Baseline and 6 months.
Relative Peri-implant Bone Density
Time frame: 6 months.
Postoperative Pain
Time frame: Postoperative days 1, 3, and 7.
Soft Tissue Healing
Time frame: 7 and 14 days postoperatively.
Implant Survival
Time frame: 12 months after implant placement.
Postoperative Infection
Time frame: 7 days, 14 days, and 4 weeks postoperatively.
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 21 Sep 2026.
- Individual participant dataSharing planned: No. Plan Description
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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.
Faculty of Dentistry Mansoura University Mansoura,, Egypt principal investigator
Faculty of Dentistry, Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Melatonin in people with Chronic Apical Periodontitis and Dental Implantation, run by Mansoura 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 6 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 21 Sep 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?
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?
Implant Stability Quotient (ISQ) (time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months after implant placement.). 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 21 Sep 2026.