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.

Dental Caries in Children Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250609
• Other study ID #: 14422021510951
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• Endocrown "composite".
It is a type of restoration has been shown a great success in adult and recently has been suggested for children

Locations

Country	Name	City	State
Egypt	Basheer MAbkhot	Cairo	Jiza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Retention	Clinical evaluation by Principle investigator. Binary (Yes/No)	one year
Primary	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
Primary	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	Radiograph in Terms of root fracture	Digital radiographic Evaluation. Binary(Yes/No)	one year