NCT04770792

Brief Summary

The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

February 9, 2021

Last Update Submit

September 14, 2021

Conditions

Indirect Pulp Treatment

Keywords

Indirect pulp treatmentDeep cariesPrimary molarsMineral trioxide aggregate2% chlorhexidine gluconate

Outcome Measures

Primary Outcomes (2)

  • Data Recording Sheet for Intraoral Clinical Examination

    Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Spontaneous pain. 2. Pain on percussion. 3. Signs of abscess or fistula. 4. Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".

    12 months

  • Data Recording Sheet for Periapical Radiographic Evaluation

    Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Radiolucency at the periapical or interradicular areas. 2. Loss of lamina dura. 3. Signs of internal root resorption. 4. Signs of external pathologic root resorption. 5. Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "no".

    12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

2% chlorhexidine gluconate with mineral trioxide aggregate.

Other: 2% chlorhexidine gluconate with mineral trioxide aggregate.

Control group

ACTIVE COMPARATOR

Mineral trioxide aggregate.

Other: Mineral trioxide aggregate.

Interventions

2% chlorhexidine gluconate with mineral trioxide aggregate.OTHER

2% chlorhexidine gluconate with mineral trioxide aggregate.

Experimental group
Mineral trioxide aggregate.OTHER

Mineral trioxide aggregate.

Control group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old.
  • Healthy.
  • Cooperative.
  • Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
  • No spontaneous pain.
  • No pain on palpation or percussion.
  • No signs of fistula or abscess.
  • No abnormal mobility.
  • No radiolucency at the periapical or interradicular areas.
  • No loss of lamina dura.
  • No radiographic signs of internal resorption.
  • Sufficient tooth structure allowing placement of rubber dam.
  • Not expected to exfoliate within 1 year.

You may not qualify if:

  • Spontaneous pain.
  • Pain on palpation or percussion.
  • Signs of fistula or abscess.
  • Presence of abnormal mobility.
  • Radiolucency at the periapical or interradicular areas.
  • Loss of lamina dura.
  • Radiographic signs of internal resorption.
  • No sufficient tooth structure allowing placement of rubber dam.
  • Expected to exfoliate within 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University

Jeddah, Mecca Region, Jeddah 21589, Saudi Arabia

Location

MeSH Terms

Interventions

chlorhexidine gluconatemineral trioxide aggregate

Study Officials

  • Afnan M Saber, MSc

    Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 25, 2021

Study Start

April 6, 2019

Primary Completion

December 31, 2020

Study Completion

June 8, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)