Implant TherapyNCT07374523
Clinical and Radiographic Evaluation of Local Melatonin Application on Osseointegration of Immediate Mandibular Implants
A study testing Melatonin gel in people with Implant Therapy, run by Suez Canal University at 1 site in Egypt.
Trial summary
Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth: A Randomized Controlled Study Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Implant Therapy
- What is being tested?
- Melatonin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Dec 2026
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 21 and 60 years.
- Good general health (ASA I).
- Non-smokers or light smokers (<10 cigarettes/day).
- Presence of a single non-restorable mandibular tooth indicated for extraction (incisor, canine, or premolar).
- Adequate bone volume to receive a dental implant.
- Patients with good oral hygiene.
Who cannot join
- Medically compromised patients (e.g., uncontrolled diabetes, immunosuppressive therapy, bisphosphonate use)
- Pregnant and lactating women.
- Active periodontal disease at the implant site.
- Acute infection at the extraction site (abscess or sinus tract).
- Severe parafunctional habits (e.g., bruxism, clenching).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth: A Randomized Controlled Study
Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth:
A Randomized Controlled Study
Read the detailed description
Dental implant is a treatment option that offers great functional and biologic advantages alongside noticeable long-term success outcomes with survival rates exceeding 95% . Delayed implant placement has been widely and successfully used for replacing missing teeth However, there are some challenges faced with delayed implant placement protocol due to the postextraction alveolar ridge resorption in buccolingual and apicocoronal directions .
The percentage of the post-extraction horizontal and vertical dimensional changes are 29-63% and 11-22% respectively . This is attributed to the disruption of vascular supply due to damage of periodontal ligament leading to pronounced bundle bone resorption . This pronounced post-extraction bone resorption usually leads to functional challenges and the need for augmentation procedures . In order to avoid such challenges, immediate post-extraction implant placement concept was introduced to avoid the bone resorption following tooth extraction and to reduce treatment time . Immediate implant placement showed a high overall implant placement rate reaching 97.1% as reported in the systematic review and 94.9% in the meta-analysis
Although immediate implant placement is effective in preservation of the alveolar bone dimensions but it fails to completely prevent the postextraction dimensional changes . Therefore, attempts were done regarding placement of various biomaterials in the peri-implant gap to increase the immediate implant stability and to minimize or even prevent the post-extraction bone dimensional changes if possible. Multiple materials were successfully used such as bone grafting materials like xenografts , autogenous graftsin addition to the application of bone morphogenetic proteins (BMPs), platelet rich fibrin (PRF) .
Melatonin (MLT) among these agents which are of a great interest for the recent researches whether in the medical or dental fields due to their confirmed physiological and structural functions, their biocompatibility and non-antigenic properties .
MLT is a natural hormone with powerful antioxidant properties, released mainly the pineal gland . It is successfully used in various conditions as sleep disorders, cardiovascular, chronic inflammatory diseases and parkinsonism
- Conditions
- Implant Therapy
- Being tested
- Melatonin gel, Control
- Keywords
- implant, clinical stability, radiographic assessment, soft tissue health, Melatonin, immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin gelOther
the implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%).
ControlOther
the implant was placed without melatonin.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin gel | Experimental | Not described Receives: Other: Melatonin gel; Other: Control |
| control without melatonin gel | Placebo comparator | Not described Receives: Other: Melatonin gel; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability (ISQ)
Implant stability will be assessed using resonance frequency analysis and recorded as Implant Stability Quotient (ISQ) values on a scale from 1 to 100, where higher values indicate greater implant stability. ISQ values ≥70 indicate high stability; values 55-69 indicate moderate stability requiring monitoring; and values <55 indicate low stability.
Measured: Immediately postoperatively and at 6months postoperatively
Secondary outcomes (4)
post-operative pain (VAS)
Postoperative pain assessed using visual analogue scale (VAS)
Visual Analog Scale (VAS) for Pain, Grades:
0 - No pain 1-3 - Mild pain (nagging, annoying, but not interfering with activities) 4-6 - Moderate pain (interferes significantly with activities) 7-10 - Severe pain (disabling, unable to perform activities)
Measured: At 1, 3 and 7 days postoperatively
post-operative Edema
Post-operative Edema Scale (Grade 0-3) Grades:
Grade 0: No edema observed Grade 1: Intraoral edema only Grade 2: Extraoral edema Grade 3: Diffuse edema involving both intraoral and extraoral areas
Measured: At 1, 3 and 7 days postoperatively
Marginal bone loss
Marginal bone loss:
Marginal bone loss will be measured using DIGORA software (Soredex, Helsinki, Finland) by calculating the vertical distance (in millimeters) from the implant shoulder/platform to the first bone-to-implant contact on the mesial and distal aspects.
Measured: Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively
Bone density
Peri-implant bone density will be assessed using DIGORA software (Soredex, Helsinki, Finland) by calculating mean gray scale values within a standardized region of interest (ROI) adjacent to the implant, where higher gray scale values indicate greater bone density.
Measured: Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant TherapyStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374523
- Sponsor's protocol ID
- 1008/2025
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07374523
- Acronym / sponsor ID
- 1008/2025
- Conditions
- Implant Therapy
- Keywords
- implant, clinical stability, radiographic assessment, soft tissue health, Melatonin, immediate implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jan 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.
Clinical and Radiographic Evaluation of Local Application of Melatonin on Osseointegration of Immediate Dental Implants for Mandibular Single Rooted Teeth:
A Randomized Controlled Study
Detailed description
Dental implant is a treatment option that offers great functional and biologic advantages alongside noticeable long-term success outcomes with survival rates exceeding 95% . Delayed implant placement has been widely and successfully used for replacing missing teeth However, there are some challenges faced with delayed implant placement protocol due to the postextraction alveolar ridge resorption in buccolingual and apicocoronal directions .
The percentage of the post-extraction horizontal and vertical dimensional changes are 29-63% and 11-22% respectively . This is attributed to the disruption of vascular supply due to damage of periodontal ligament leading to pronounced bundle bone resorption . This pronounced post-extraction bone resorption usually leads to functional challenges and the need for augmentation procedures . In order to avoid such challenges, immediate post-extraction implant placement concept was introduced to avoid the bone resorption following tooth extraction and to reduce treatment time . Immediate implant placement showed a high overall implant placement rate reaching 97.1% as reported in the systematic review and 94.9% in the meta-analysis
Although immediate implant placement is effective in preservation of the alveolar bone dimensions but it fails to completely prevent the postextraction dimensional changes . Therefore, attempts were done regarding placement of various biomaterials in the peri-implant gap to increase the immediate implant stability and to minimize or even prevent the post-extraction bone dimensional changes if possible. Multiple materials were successfully used such as bone grafting materials like xenografts , autogenous graftsin addition to the application of bone morphogenetic proteins (BMPs), platelet rich fibrin (PRF) .
Melatonin (MLT) among these agents which are of a great interest for the recent researches whether in the medical or dental fields due to their confirmed physiological and structural functions, their biocompatibility and non-antigenic properties .
MLT is a natural hormone with powerful antioxidant properties, released mainly the pineal gland . It is successfully used in various conditions as sleep disorders, cardiovascular, chronic inflammatory diseases and parkinsonism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin gel | Experimental | Other: Melatonin gel, Other: Control |
| control without melatonin gel | Placebo comparator | Other: Melatonin gel, Other: Control |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged between 21 and 60 years.
- Good general health (ASA I).
- Non-smokers or light smokers (<10 cigarettes/day).
- Presence of a single non-restorable mandibular tooth indicated for extraction (incisor, canine, or premolar).
- Adequate bone volume to receive a dental implant.
Key exclusion criteria (5 listed)
- Medically compromised patients (e.g., uncontrolled diabetes, immunosuppressive therapy, bisphosphonate use)
- Pregnant and lactating women.
- Active periodontal disease at the implant site.
- Acute infection at the extraction site (abscess or sinus tract).
- Severe parafunctional habits (e.g., bruxism, clenching).
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 gelthe implant was placed with melatonin application (3mg Melatonin into 2ml of Hydroxyethyl Cellulose Gel 2%). | Other | Melatonin gel, control without melatonin gel |
| Controlthe implant was placed without melatonin. | Other | Melatonin gel, control without melatonin gel |
Primary outcome
Implant stability (ISQ)
Time frame: Immediately postoperatively and at 6months postoperatively
Implant stability will be assessed using resonance frequency analysis and recorded as Implant Stability Quotient (ISQ) values on a scale from 1 to 100, where higher values indicate greater implant stability. ISQ values ≥70 indicate high stability; values 55-69 indicate moderate stability requiring monitoring; and values <55 indicate low stability.
4 secondary outcomes
post-operative pain (VAS)
Time frame: At 1, 3 and 7 days postoperatively
post-operative Edema
Time frame: At 1, 3 and 7 days postoperatively
Marginal bone loss
Time frame: Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively
Bone density
Time frame: Immediately postoperatively (baseline) 3 months postoperatively 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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 gel in people with Implant Therapy, run by Suez Canal 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 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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. Some participants in this study may receive a placebo. 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?
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 (ISQ) (time frame: Immediately postoperatively and at 6months postoperatively). 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 29 Apr 2026.