Back to resultsAssessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
Primary Purpose
Periodontitis (Stage 3)
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Autogenous demineralized dentin nanoparticles
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis (Stage 3)
Eligibility Criteria
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.
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Open flap debridement + allograft bone (Maxgraft)
Open flap debridement + Autogenous demineralized nanoparticles
Arm Description
Outcomes
Primary Outcome Measures
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.
Clinical attachment level
Clinical attachment level was measured at baseline and 6 months
Probing pocket depth
Probing pocket depth was measured at baseline and 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].
Secondary Outcome Measures
Plaque Index
plaque index was measured at baseline, 3, 6 months
Gingival index
Gingival index was measured at baseline, 3, 6 months
Full Information
NCT ID
NCT05258006
First Posted
February 10, 2022
Last Updated
February 22, 2022
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT05258006
Brief Title
Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
Official Title
Clinical and Radiographic Assessment of Autogenous Dentin Nanoparticles in Treatment of Stage III Periodontitis: A Split-Mouth Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis (Stage 3)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open flap debridement + allograft bone (Maxgraft)
Arm Type
Placebo Comparator
Arm Title
Open flap debridement + Autogenous demineralized nanoparticles
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Autogenous demineralized dentin nanoparticles
Intervention Description
Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect
Primary Outcome Measure Information:
Title
Vertical bone loss
Description
vertical bone loss was measured from cementoenamel junction (CEJ) to the base of the bone defect in each site in group I & II.
Time Frame
6 months
Title
Clinical attachment level
Description
Clinical attachment level was measured at baseline and 6 months
Time Frame
6 months
Title
Probing pocket depth
Description
Probing pocket depth was measured at baseline and 6 months
Time Frame
6 months
Title
Bone gain
Description
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].
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plaque Index
Description
plaque index was measured at baseline, 3, 6 months
Time Frame
6 months
Title
Gingival index
Description
Gingival index was measured at baseline, 3, 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
October 6 University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of Autogenous Dentin Graft in Treatment of Infra-bony Defect
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