Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endocrown "composite".
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- Excessive mobility.
- Children with underlying systemic disease.
- Children with special health care needs.
- Poor oral hygiene.
Sites / Locations
- Basheer MAbkhot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention: Endocrown "composite".
Comparator / Control: Stainless steel crown.
Arm Description
Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar
Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar
Outcomes
Primary Outcome Measures
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.
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.
Retention
Clinical evaluation by Principle investigator. Binary (Yes/No)
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
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.
Secondary Outcome Measures
Radiograph in Terms of root fracture
Digital radiographic Evaluation. Binary(Yes/No)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250609
Brief Title
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
Official Title
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Diagnostic procedure:
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken
Intra operative procedure:
Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.
The immediate postoperative radiograph will be done to reveal optimal root canal treatment.
In the intervention group:
The preparation of cavity design will be as following:
Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction between the occlusal and mesial cavity will be rounded to produce cervical side walk. • Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded end (TR- Dia Bur Mani).
Impression will be taken for the prepared tooth structure using addition silicone material (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown restoration will be cemented in place using self-adhesive universal dual cured resin cement (rely X Unicem, 3M, USA).
In the control group tooth preparation will be made as follow:
By reducing mesial, distal and occlusal surface. The crown margin will be placed just apically to the gingival margin and carefully adjusted to give an accurate fit in this region. The crown will be cemented with glass ionomer cement.
Follow up:
Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph evaluation will be performed at, 1 st week, 6 and 12 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The statistician will be blinded throughout the whole procedures (double blind). Principle investigator will be responsible for all clinical procedures.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Endocrown "composite".
Arm Type
Experimental
Arm Description
Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar
Arm Title
Comparator / Control: Stainless steel crown.
Arm Type
No Intervention
Arm Description
Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar
Intervention Type
Other
Intervention Name(s)
Endocrown "composite".
Intervention Description
It is a type of restoration has been shown a great success in adult and recently has been suggested for children
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
one year
Title
Gingival bleeding
Description
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.
Time Frame
one year
Title
Retention
Description
Clinical evaluation by Principle investigator. Binary (Yes/No)
Time Frame
one year
Title
Patient satisfaction
Description
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
Time Frame
one year
Title
Probing pocket depth (PPD)
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Radiograph in Terms of root fracture
Description
Digital radiographic Evaluation. Binary(Yes/No)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Excessive mobility.
Children with underlying systemic disease.
Children with special health care needs.
Poor oral hygiene.
Facility Information:
Facility Name
Basheer MAbkhot
City
Cairo
State/Province
Jiza
ZIP/Postal Code
12511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
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