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

Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Periodontitis (Stage 3)
• Intervention / Treatment: Procedure: Autogenous demineralized dentin nanoparticles

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Open flap debridement + allograft bone (Maxgraft)	Procedure: Autogenous demineralized dentin nanoparticles; Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect
Active Comparator: Open flap debridement + Autogenous demineralized nanoparticles	Procedure: Autogenous demineralized dentin nanoparticles; Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone loss	vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I & II.	6 months
Clinical attachment level	Clinical attachment level was measured at baseline and 6 months	6 months
Probing pocket depth	Probing pocket depth was measured at baseline and 6 months	6 months
Bone gain	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].	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	plaque index was measured at baseline, 3, 6 months	6 months
Gingival index	Gingival index was measured at baseline, 3, 6 months	6 months

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No