NCT03670979

Brief Summary

This study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

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 5, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

August 1, 2018

Last Update Submit

February 13, 2023

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Radiographic evaluation

    removing the defect as seen in radiograph defect filling with bone swaging with edta and bone substitute

    3 months

Secondary Outcomes (1)

  • Clinical pocket depth

    3month

Study Arms (2)

bone swaging alone

EXPERIMENTAL

xenograft alone

Procedure: bone swaging

bone swaging plus EDTA

EXPERIMENTAL

bone swaging with EDTA

Procedure: bone swaging

Interventions

bone swagingPROCEDURE

osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone

bone swaging alonebone swaging plus EDTA

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • good compliance with plaque control instructions following initial therapy
  • teeth involved were all vital with no mobility ;
  • each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;

You may not qualify if:

  • no systemic diseases which could influence the outcome of therapy;
  • absence of periodontal treatment during the previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • ahmed y gamal, professor

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, periodontology department

Study Record Dates

First Submitted

August 1, 2018

First Posted

September 14, 2018

Study Start

January 5, 2016

Primary Completion

January 5, 2017

Study Completion

January 5, 2017

Last Updated

February 14, 2023

Record last verified: 2023-02