Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSuez Canal University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age above 20 years
Non-restorable maxillary premolar teeth
Candidates for immediate implant placement
Intact socket walls
Disqualifiers
Heavy smokers
Bruxism or clenching
Uncontrolled systemic disease
Chemotherapy/radiotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous Demineralized Dentin Graft
Procedure/SurgeryAutologous 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 gel
DrugMelatonin 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: ADDG AloneExperimental treatment 1 intervention
Group B: ADDG + Melatonin GelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Implant Stability Quotient (ISQ)
Measured using Penguin device immediately after implant placement and after 6 months.
Time frame
Baseline and 6 months2
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.
Time frame
Immediate postoperative and 9 months after implant placement3
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.
Time frame
Immediate postoperative and 9 months after implant placementSecondary outcomes
1
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.
Time frame
Immediate postoperative, and 9 months after implant placement2
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.
Time frame
Baseline (immediately after implant placement) and 9-month follow-up3
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.
Time frame
Baseline, 6 months, and 9 months4
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.
Time frame
Baseline, 6 months, and 9 monthsSponsors and contacts
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Source ClinicalTrials.gov