Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial
1 other identifier
interventional
54
1 country
1
Brief Summary
The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedStudy Start
First participant enrolled
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2025
CompletedDecember 15, 2025
December 1, 2025
12 months
April 16, 2024
December 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
buccal ridge height change in mm
Difference in height linear measurements between baseline and final CBCT scans
6 months
Secondary Outcomes (5)
Alveolar ridge bucco-lingual width change in mm
6 months
Histomorphometric analysis
6 months
palatal ridge height change in mm
6 months
the need for additional augmentation during implant placement
6 months
patient discomfort and pain
7 days postoperatively
Study Arms (3)
Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole
EXPERIMENTALAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using demineralized dentin combined with I-PRF
EXPERIMENTALAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be mixed with the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using autogenous demineralized dentin graft alone
ACTIVE COMPARATORAtraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and inserted in the extraction socket and covered then suturing
Interventions
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be added to the particulate demineralized dentin graft forming sticky demineralized tooth graft then inserted in the extraction socket and covered then suturing
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid inserted in the extraction socket as particulate demineralized dentin graft
Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft forming sticky demineralized tooth graft with slowly released metronidazole then inserted in the extraction socket and covered then suturing
Eligibility Criteria
You may qualify if:
- Non-restorable tooth indicated for extraction in esthetic maxillary zone
- Anterior or premolar teeth
- Apical chronic pathosis
- Motivated patients, agree to sign informed consent and complete the follow-up period
- FMPS of \<15% and a FMBS \<10%
You may not qualify if:
- Pregnant or lactating females
- Active infection at extraction site
- Smokers
- Systemic conditions affecting healing (e.g. diabetes, Paget disease or hyperthyroidism, medications as bisphosphonates...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry
Cairo, Egypt
Related Publications (4)
Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PMID: 23163915BACKGROUNDElfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
PMID: 33565656BACKGROUNDvan Orten A, Goetz W, Bilhan H. Tooth-Derived Granules in Combination with Platelet-Rich Fibrin ("Sticky Tooth") in Socket Preservation: A Histological Evaluation. Dent J (Basel). 2022 Feb 16;10(2):29. doi: 10.3390/dj10020029.
PMID: 35200254BACKGROUNDElbehwashy MT, Hosny MM, Elfana A, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft-Based Strategies With or Without I-PRF and Metronidazole for Ridge Preservation in Infected Sockets: A Randomized Clinical Trial. J Periodontal Res. 2026 Feb 20. doi: 10.1111/jre.70092. Online ahead of print.
PMID: 41717869DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator. Mohamed Elbehwashy
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 19, 2024
Study Start
May 20, 2024
Primary Completion
May 2, 2025
Study Completion
June 28, 2025
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
the results will be shared with other researchers