NCT05921500

Brief Summary

clinical and radiographic evaluation the intracoronal bleaching of primary anterior teeth using sodium perborate with walking bleach technique

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 3, 2023

Last Update Submit

June 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical evaluation of internal bleaching of primary teeth

    Clinical outcomes: During the follow-up period- two weeks to month, signs of any pathology will be observed clinically and scored as follow: 1. Sensitivity to percussion or palpation (positive or negative). 2. Abscess or fistulae (positive or negative). 3. Color change recorded by vita shade 3d master.

    two weeks to month

Secondary Outcomes (1)

  • radiographic evaluation of internal bleaching of primary teeth

    six months

Study Arms (1)

Internal bleaching of discolored primary anterior teeth by using sodium peborate

EXPERIMENTAL

Internal bleaching of discolored primary anterior teeth by using sodium peborate

Drug: sodium peborate

Interventions

Internal bleaching of discolored primary anterior teeth by using sodium peborate

Internal bleaching of discolored primary anterior teeth by using sodium peborate

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 3-5 years.
  • Parents/caregivers acceptance.
  • Traumatized anterior teeth with sensitivity to percussion and palpation with gray discoloration.
  • Discolored anterior teeth indicated for intracoronal bleaching.
  • Traumatized anterior teeth no response to an electric pulp test.
  • Discolored teeth with satisfactorily previously obturated root canal .
  • Absence of preapical lesions or apex resorption.

You may not qualify if:

  • Teeth with signs tooth mobility indicated for extraction.
  • Teeth with vertical root fracture.
  • Teeth with preapical lesions or apex resorption.
  • Teeth with discolorations from restorative materials.
  • Children with lack of cooperation for post-operative recall and follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasser Mohammed Bedir

Tanta, Egypt

Location

Related Publications (2)

  • Arikan V, Sari S, Sonmez H. Bleaching a devital primary tooth using sodium perborate with walking bleach technique: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):e80-4. doi: 10.1016/j.tripleo.2009.01.050.

    PMID: 19426913BACKGROUND
  • Sharma DS, Barjatya K, Agrawal A. Intra-coronal bleaching in young permanent and primary tooth with biologic perspectives. J Clin Pediatr Dent. 2011 Summer;35(4):349-52. doi: 10.17796/jcpd.35.4.p372w1h5j2kg5734.

    PMID: 22046690BACKGROUND

Study Officials

  • alaa eldin mohamed, associate professor

    associate professor

    STUDY DIRECTOR
  • hamdy badreldin, lecture

    lecture

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cairo

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 27, 2023

Study Start

May 1, 2022

Primary Completion

May 1, 2022

Study Completion

August 1, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations