Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation

NCT05470673 | Unknown

• 1 other identifier: perio2022ARP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 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 (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge apico-coronal height change in mm

  Difference in height linear measurements between baseline and final CBCT scans

  6 months

Secondary Outcomes (2)

• Alveolar ridge bucco-lingual width change in mm

  6 months

• Histological assessment

  6 months

Study Arms (2)

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 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

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

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

Alveolar ridge preservation using autogenous demineralized dentin graft alone PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-restorable tooth indicated for extraction
• Single-rooted teeth
• Inactive infection related to the tooth
• Motivated patients, agree to sign informed consent and complete the follow-up period

You may not qualify if:

• Pregnant females
• Active infection at extraction site
• Smokers
• Systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry

Cairo, Egypt

Location

Related Publications (3)

• 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: 23163915 BACKGROUND

• 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: 33565656 BACKGROUND

• 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: 35200254 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohamed Talaat, Master Degree

CONTACT

+201009174617; Mohamed.Talaat@dentistry.cu.edu.eg

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: July 20, 2022
• First Posted: July 22, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

EG (1)