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Endocrown Restoring First Permanent Molar in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06432049
Enrollment
30
Registered
2024-05-29
Start date
2022-12-05
Completion date
2024-05-13
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children

Keywords

Endocrown, CAD-CAM, Children, Ceramic, Molars

Brief summary

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

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.

Interventions

OTHERrestoration for endodontically treated molar

prefabricated stainless steel crown or endocrown

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effect of different restoration on surrounding gingiva6 monthsgingival 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.
number of participants with pathological changes in radiographs6 monthsperiodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
degree of parent satisfaction with different restorations6 monthevaluation 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.
rate of plaque accumulation on different type of restorations6 monthsplaque 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.

Secondary

MeasureTime frameDescription
number of participants with pathological changes in radiographs1 yearperiodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
degree of parent satisfaction with different restorations1 yearusing a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
rate of plaque accumulation on different type of restorations1 yearplaque 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.
effect of different restoration on surrounding gingiva1 yeargingival 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026