Kafr El Shaikh University
Kafr ash Shaykh, 6860404, Egypt
Completed
NCT Number: NCT06432049
Endocrown Restoring First Permanent Molar in Children
Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months
Completed
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Notify MeKey information
Age range
10 year–13 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
restoration for endodontically treated molar
Otherprefabricated stainless steel crown or endocrown
Primary outcomes
-
number of participants with pathological changes in radiographs
Time frame: 6 months
periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
-
degree of parent satisfaction with different restorations
Time frame: 6 month
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.
-
rate of plaque accumulation on different type of restorations
Time frame: 6 months
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.
-
effect of different restoration on surrounding gingiva
Time frame: 6 months
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.
Secondary outcomes
-
number of participants with pathological changes in radiographs
Time frame: 1 year
periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
-
degree of parent satisfaction with different restorations
Time frame: 1 year
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 restorations
Time frame: 1 year
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.
-
effect of different restoration on surrounding gingiva
Time frame: 1 year
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.
Sponsors and collaborators
Lead sponsor
Kafrelsheikh University
Other
Registry information
Official study title
Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2024
- First posted
- May 29, 2024
- Registry last updated
- May 29, 2024
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.