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OpenTrials
Completed

NCT Number: NCT05250609

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.

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.

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Key information

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basheer MAbkhot

Cairo, Jiza, 12511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endocrown "composite".

Other

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

Primary outcomes

  1. Postoperative pain

    Time frame: one year

    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.

  2. Gingival bleeding

    Time frame: one year

    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.

  3. Retention

    Time frame: one year

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

  4. Patient satisfaction

    Time frame: one year

    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

  5. Probing pocket depth (PPD)

    Time frame: one year

    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 outcomes

  1. Radiograph in Terms of root fracture

    Time frame: one year

    Digital radiographic Evaluation. Binary(Yes/No)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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