NCT05258006

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 10, 2022

Last Update Submit

February 22, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Plaque Index

    6 months

  • Gingival index

    6 months

Study Arms (2)

Open flap debridement + allograft bone (Maxgraft)

PLACEBO COMPARATOR
Procedure: Autogenous demineralized dentin nanoparticles

Open flap debridement + Autogenous demineralized nanoparticles

ACTIVE COMPARATOR
Procedure: Autogenous demineralized dentin nanoparticles

Interventions

Effect of Autogenous demineralized dentin nanoparticles in bone gain in infrabony defect

Open flap debridement + Autogenous demineralized nanoparticlesOpen flap debridement + allograft bone (Maxgraft)

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Cairo, Egypt

Location

Related Publications (1)

  • Elgendy EA, Elgendy AM, ElBorady OM. Clinical And Radiographic Assessment Of Autogenous Dentin Nanoparticles In Treatment Of Stage Iii Periodontitis: A Split-Mouth Clinical Study. J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S310-S316. doi: 10.47391/JPMA.EGY-S4-60.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Periodontology

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 25, 2022

Study Start

January 1, 2021

Primary Completion

November 1, 2021

Study Completion

January 1, 2022

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations