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

• Sponsor: October 6 University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05258006
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periodontitis (Stage 3)	Procedure: Autogenous demineralized dentin nanoparticles	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Nov 1, 2021
• Actual Study Completion Date: Jan 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Clinical attachment level [6 months]

   Clinical attachment level was measured at baseline and 6 months

3. Probing pocket depth [6 months]

   Probing pocket depth was measured at baseline and 6 months

4. 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].

Secondary Outcome Measures

1. Plaque Index [6 months]

   plaque index was measured at baseline, 3, 6 months

2. Gingival index [6 months]

   Gingival index was measured at baseline, 3, 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University	Cairo		Egypt

Sponsors and Collaborators

• October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enas Elgendy, Professor of Periodontology, October 6 University
• ClinicalTrials.gov Identifier: NCT05258006
• Other Study ID Numbers: 4
• First Posted: Feb 25, 2022
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis

Study Results

No Results Posted as of Feb 25, 2022