NCT05250609

Brief Summary

management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

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

First Submitted

Initial submission to the registry

February 5, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

February 5, 2022

Last Update Submit

September 29, 2023

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (5)

  • Postoperative pain

    Will be recorded by using modified wong-baker pain scale (0 -3). Zero= no pain, 1= slight pain, 2=moderate pain, 3= severe pain. Principle investigator will ask the patient about the pain.

    one year

  • Gingival bleeding

    Gingival Index(GI)Scale (0-3): score 0: normal gingiva, score1: mild inflammation, slight change in colour, slight oedema, no bleeding on probing, score2: moderate inflammation, redness, oedema, and glazing, bleeding on probing, score3: severe inflammation, marked redness and oedema, ulceration tendency to spontaneous bleeding.

    one year

  • Retention

    Clinical evaluation by Principle investigator. Binary (Yes/No)

    one year

  • Patient satisfaction

    Patient and guardian satisfaction with restorative treatment was classified as (score from 1-4) 1= very dissatisfied, 2= dissatisfied, 3= satisfied and 4= very satisfied

    one year

  • Probing pocket depth (PPD)

    Periodontal probe. (1-5 mm):It will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and will be moved in a walking fashion.

    one year

Secondary Outcomes (1)

  • Radiograph in Terms of root fracture

    one year

Study Arms (2)

Intervention: Endocrown "composite".

EXPERIMENTAL

Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar

Other: Endocrown "composite".

Comparator / Control: Stainless steel crown.

NO INTERVENTION

Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar

Interventions

Endocrown "composite".OTHER

It is a type of restoration has been shown a great success in adult and recently has been suggested for children

Intervention: Endocrown "composite".

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cooperative children in age range from 10 to 13 years
  • Mandibular first permanent molar indicated for root canal treatment with closed apex.
  • Presence of at least two to three sound walls of tooth.
  • Absence of internal or external pathologic root resorption.
  • Normal occlusion without any para-functional habits.
  • Parent or guardian agree for participant in the study

You may not qualify if:

  • Excessive mobility.
  • Children with underlying systemic disease.
  • Children with special health care needs.
  • Poor oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basheer MAbkhot

Cairo, Jiza, 12511, Egypt

Location

Related Publications (1)

  • Mabkhot BA, Taha SEE, Sabry SM. Clinical and radiographic assessment of composite CAD/CAM endocrowns and stainless steel crowns for endodontically treated first permanent molars in Egyptian children: randomized controlled pilot study. BMC Oral Health. 2025 May 31;25(1):864. doi: 10.1186/s12903-025-06192-y.

    PMID: 40450229DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The statistician will be blinded throughout the whole procedures (double blind). Principle investigator will be responsible for all clinical procedures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 22, 2022

Study Start

August 1, 2022

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations

EG(1)