NCT06374784

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

April 16, 2024

Last Update Submit

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

EXPERIMENTAL

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 then inserted in the extraction socket and covered then suturing

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole

Alveolar ridge preservation using demineralized dentin combined with I-PRF

EXPERIMENTAL

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 mixed with the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF

Alveolar ridge preservation using autogenous demineralized dentin graft alone

ACTIVE COMPARATOR

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 inserted in the extraction socket and covered then suturing

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft alone

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

Alveolar ridge preservation using demineralized dentin combined with I-PRF

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

Alveolar ridge preservation using autogenous demineralized dentin graft alone

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

Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

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: 23163915BACKGROUND
  • Elfana 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: 33565656BACKGROUND
  • van 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: 35200254BACKGROUND
  • Elbehwashy 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.

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

Locations