Endocrown Restoring First Permanent Molar in Children

Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study

Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months

Study Overview

• Status: Completed
• Conditions: Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children
• Intervention / Treatment: Other: restoration for endodontically treated molar

Detailed Description

This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 6860404
    • Kafr El Shaikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient age ranging from 10-13 years old with closed apex.
• Normal occlusion without any para-functional habits.
• Decayed lower first molar.
• Supra-gingival margin was required after preparation.
• Absence of root fractures or cracks.

Exclusion Criteria:

• Difficulty to apply rubber dam for proper endocrown bonding.
• Lack of patient cooperation for post-operative recall and follow up.
• Bad oral hygiene

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMC; endodontically treated molar restored with Stainless steel crown	Other: restoration for endodontically treated molar; prefabricated stainless steel crown or endocrown
Experimental: EMX; endodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate	Other: restoration for endodontically treated molar; prefabricated stainless steel crown or endocrown
Experimental: COP; endodontically treated molar restored with endocrown fabricated from CAD-CAM composite	Other: restoration for endodontically treated molar; prefabricated stainless steel crown or endocrown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with pathological changes in radiographs	periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings	6 months
degree of parent satisfaction with different restorations	evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.	6 month
rate of plaque accumulation on different type of restorations	plaque index evaluate the plaque accumulation around different type of restorations. this index involves: Plaque index 0: No plaque is in the area adjacent to the gingiva.; Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.; Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.; Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.	6 months
effect of different restoration on surrounding gingiva	gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with pathological changes in radiographs	periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings	1 year
degree of parent satisfaction with different restorations	using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.	1 year
rate of plaque accumulation on different type of restorations	plaque index evaluate the plaque accumulation around different type of restorations. this index involves: Plaque index 0: No plaque is in the area adjacent to the gingiva.; Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.; Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.; Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.	1 year
effect of different restoration on surrounding gingiva	gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.	1 year

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Children; Ceramic; CAD-CAM; Endocrown; Molars
• Other Study ID Numbers: MKSU/22-11-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: all data will be shared after publishing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No