Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect

Not Applicable

Completed

• Conditions: Periodontitis (Stage 3)
• Interventions: Procedure: Autogenous demineralized dentin nanoparticles

• Registration Number: NCT05258006
• Lead Sponsor: October 6 University

Brief Summary

The aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.

Detailed Description

In this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage III periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-22
• Last Update Submitted: 2022-02-22
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with good systemic health and no contraindication for periodontal surgery.
• Patients who are able to maintain good oral hygiene.
• Gingival thickness for the site selected should be ≥1mm.
• Probing depth of ≥ 6mm.
• Patient has at least one hopeless teeth

Exclusion Criteria

• Active infectious diseases (hepatitis, tubercu¬losis, HIV, etc....).
• Medically compromised patients.
• Smokers and alcoholic abusers
• People who suffer from any systemic disease that affect the periodontium.
• Pregnant, postmenopausal women.
• People who take anti-inflammatory drugs, anti¬biotics or vitamins within the previous 3 month.
• People who use mouth washes regularly
• Participants in other clinical trials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open flap debridement + allograft bone (Maxgraft)	Autogenous demineralized dentin nanoparticles	-
Open flap debridement + Autogenous demineralized nanoparticles	Autogenous demineralized dentin nanoparticles	-

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	6 months	Clinical attachment level was measured at baseline and 6 months
Bone gain	6 months	The bone gain is calculated by: * Preoperative VBL (at baseline): measured as the distance from cementoenamel junction (CEJ) to the base of the bone defect.; * Postoperative VBL (after 6 months) measured as the distance from cementoenamel junction (CEJ) to the base of the bone formation.; * Postoperative bone fill (bone gain after 6 months) \[measured by subtracting the preoperative VBL from the postoperative VBL\].
Vertical bone loss	6 months	vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I \& II.
Probing pocket depth	6 months	Probing pocket depth was measured at baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Plaque Index	6 months	plaque index was measured at baseline, 3, 6 months
Gingival index	6 months	Gingival index was measured at baseline, 3, 6 months

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Cairo, Egypt