Actively Recruiting
Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
Led by Suez Canal University · Updated on 2026-05-28
16
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies patients who need extraction and immediate dental implant placement in the upper premolar area. It evaluates the effect of using an autologous demineralized dentin graft (ADDG), either alone or combined with melatonin gel, on helping the implant bond with the bone, a process called osseointegration. The study aims to see if melatonin, an antioxidant that may promote bone healing, improves implant success and healing outcomes over 9 months. Participants will be randomly assigned to one of two groups. One group receives immediate implant placement with the gap around the implant filled using ADDG alone, made from the patient’s extracted tooth processed into graft material. The other group receives the same graft mixed with melatonin gel applied locally around the implant. Both groups will have their implants placed in the maxillary premolar region using standard surgical techniques. Throughout the 9-month follow-up, patients will undergo clinical exams and imaging to measure implant stability, gum health, bone loss, bone thickness, and bone density at various times. Assessments include probing depth, bleeding index, and cone beam CT scans. The study tracks changes from baseline to 6 and 9 months after implant placement to compare healing and bone integration between the two treatment methods.
CONDITIONS
Brief Title
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap greater than 2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
You will not qualify if you...
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy or radiotherapy
- Immunocompromised patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up assessments up to 9 months
Participants undergo extraction of non-restorable maxillary premolar teeth and immediate implant placement. The jumping gap around the implant is filled with autologous demineralized dentin graft either alone or mixed with melatonin gel to support osseointegration and bone healing.
Baseline visit at implant placement and follow-up visits at 6 months and 9 months
Duration - Up to 9 months post-implant placement
Participants receive clinical and radiographic evaluations to monitor implant stability, bone healing, and peri-implant health up to 9 months after implant placement.
Follow-up visits at 6 months and 9 months post-procedure
Trial Site Locations
Total: 1 location
1
Suez Canal University, Faculty of Dentistry
Ismailia, Egypt
Actively Recruiting
Research Team
B
B.S.D Abd El Fattah ELSaid Attia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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