Dental ImplantsNCT07610876
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
A study testing Autologous Demineralized Dentin Graft and Melatonin gel in people with Dental Implants and Immediate Implant Placement, run by Suez Canal University at 1 site in Egypt.
Trial summary
This randomized clinical study aims to evaluate the effect of autologous demineralized dentin graft (ADDG) with or without melatonin gel on the osseointegration of immediately placed dental implants in the maxillary premolar region. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Immediate Implant Placement, Osseointegration
- What is being tested?
- Autologous Demineralized Dentin Graft and Melatonin gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2025to 15 Oct 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
Who cannot join
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
This randomized clinical study aims to evaluate the effect of autologous demineralized dentin graft (ADDG) with or without melatonin gel on the osseointegration of immediately placed dental implants in the maxillary premolar region. Thirty patients requiring extraction and immediate implant placement will be randomly allocated into two groups. Clinical and radiographic outcomes including implant stability, peri-implant probing depth, modified bleeding index, marginal bone loss, buccal bone thickness, and bone density will be evaluated over a 9-month follow-up period.
Read the detailed description
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Thirty patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess buccal bone thickness, crestal Bone Height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
- Being tested
- Autologous Demineralized Dentin Graft, Melatonin gel
- Keywords
- Melatonin, Dentin graft, Immediate implant, ADDG, Osseointegration, CBCT, Dental implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Demineralized Dentin GraftProcedure or surgery
Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants. Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.
Melatonin gelDrug
Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.
| Study group | Role | What they receive |
|---|---|---|
| ADDG Alone | Experimental | Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period. Receives: Procedure: Autologous Demineralized Dentin Graft |
| ADDG + Melatonin Gel | Experimental | Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period. Receives: Drug: Melatonin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
Measured using Penguin device immediately after implant placement and after 6 months.
Measured: Baseline and 6 months
Jumping Distance
The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
Measured: Immediate postoperative and 9 months after implant placement
Bone Density
Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
Measured: Immediate postoperative and 9 months after implant placement
Secondary outcomes (4)
Buccal Bone Thickness (BBT)
Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.
Measured: Immediate postoperative, and 9 months after implant placement
Crestal Bone Height (CBH)
CBH was measured from the implant platform to the most coronal crestal bone at the mesial, distal, buccal, and palatal aspects using standardized CBCT images.
Measured: Baseline (immediately after implant placement) and 9-month follow-up
Peri-Implant Sulcus Depth (PISD)
Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
Measured: Baseline, 6 months, and 9 months
Modified Bleeding on Probing Index (MBOP)
Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
Measured: Baseline, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start11 Aug 2025
- Primary completion10 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd El Fattah ELSaid Attia Mowafy, Suez Canal University
- Investigators
- Hany Kamel Shalaby, Study chair, Professor of Oral Medicine and Periodontology, Dean Faculty of DentistryShaima Mohammed Morsy, Study director, Assistant Professor of Oral Medicine and PeriodontologyRasha El-Sayed Afifi, Study director, Lecturer of Oral Medicine and PeriodontologyAbd El Fattah ELSaid Attia, B.S.D, Principal investigator, B.S.D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610876
- Sponsor's protocol ID
- 854/2024
- Status last verified
- Aug 2026
- First submitted
- 20 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07610876
- Acronym / sponsor ID
- 854/2024
- Keywords
- Melatonin, Dentin graft, Immediate implant, ADDG, Osseointegration, CBCT, Dental implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 28 May 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.
This randomized clinical study aims to evaluate the effect of autologous demineralized dentin graft (ADDG) with or without melatonin gel on the osseointegration of immediately placed dental implants in the maxillary premolar region. Thirty patients requiring extraction and immediate implant placement will be randomly allocated into two groups. Clinical and radiographic outcomes including implant stability, peri-implant probing depth, modified bleeding index, marginal bone loss, buccal bone thickness, and bone density will be evaluated over a 9-month follow-up period.
Detailed description
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Thirty patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess buccal bone thickness, crestal Bone Height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADDG Alone | Experimental | Procedure: Autologous Demineralized Dentin GraftParticipants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period. |
| ADDG + Melatonin Gel | Experimental | Drug: Melatonin gelParticipants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth. Clinical and radiographic evaluation will be performed during the follow-up period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
Key exclusion criteria (5 listed)
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
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 |
|---|---|---|
| Autologous Demineralized Dentin GraftAutologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants. Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement. | Procedure or surgery | ADDG Alone |
| Melatonin gelMelatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing. | Drug | ADDG + Melatonin Gel |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Baseline and 6 months
Measured using Penguin device immediately after implant placement and after 6 months.
Jumping Distance
Time frame: Immediate postoperative and 9 months after implant placement
The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
Bone Density
Time frame: Immediate postoperative and 9 months after implant placement
Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
4 secondary outcomes
Buccal Bone Thickness (BBT)
Time frame: Immediate postoperative, and 9 months after implant placement
Crestal Bone Height (CBH)
Time frame: Baseline (immediately after implant placement) and 9-month follow-up
Peri-Implant Sulcus Depth (PISD)
Time frame: Baseline, 6 months, and 9 months
Modified Bleeding on Probing Index (MBOP)
Time frame: Baseline, 6 months, and 9 months
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Hany Kamel Shalaby study chair
Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
Shaima Mohammed Morsy study director
Assistant Professor of Oral Medicine and Periodontology
Rasha El-Sayed Afifi study director
Lecturer of Oral Medicine and Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Demineralized Dentin Graft and Melatonin gel in people with Dental Implants and Immediate Implant Placement, 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 8 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: finished, as of the sponsor's last update on 22 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?
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 and 6 months). The study lists 3 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 22 Oct 2026.