Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029023
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-07-22
Brief Title:
Clinical And Radiographic Evaluation Of Nano-Propolis Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Clinical And Radiographic Evaluation of Nano-Propolis Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate clinical and radiographic effect of nano propolis and nano curcumin as direct pulp capping agents in young permanent teeth
Detailed Description:
I Materials
1 Mineral trioxide aggregate MTA
2 Nano propolis
3 Nano curcumin
4 Glass ionomer
II Methods
Sample size calculation
Sample size calculation was performed using GPower version 3197 based on the results of a previous study The predicted sample size n was 54 ie 18 samples per group of the three groups to detect results of dentin bridge thickness
Sample preparation
Patients will be recruited from the department of Pediatric Dentistry and Dental Public Heath October 6 university The study sample will be recruited among the children between 7 to 13 years old The young permanent tooth eruption stage will be determined by the patients age and radiographic evaluation before enrolling in the research study
Before treatment a periapical radiograph will be taken with ultra-low dose mode to assess the tooth radiographically for any sign of irreversible pulpitis
Each tooth will be infiltrated with local anesthesia using 4 articaine with 1100000 epinephrine Septanest Septodont France The tooth will be isolated with a rubber dam and washed with 012 chlorhexidine The cavity will be prepared and the infected enamel and dentin will be removed with a round bur The carious dentin close to the pulp will be removed using a spoon excavator The pulp exposure position will be identified and the inflamed pulp tissue 15-2 mm will be gently removed using an abrasive diamond bur at high speed with copious sterilized normal saline The remaining healthy pulp will be rinsed with 25 sodium hypochlorite and moist sterilized cotton pellets will be placed over the pulp stumps with light pressure for 2 min to achieve hemostasis If the bleeding could not be controlled the tooth will be excluded from this study MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturers recommendation To cover the exposure area MTA and or nano propolis or nano curcumin will be placed using an amalgam carrier and non-toothed Adson forceps respectively The cavities will be lined with glass ionomer cement Vitrebond 3M ESPE St Paul MN USA and a permanent composite restoration Filtex Z350 3M ESPE Salt Lake City UT USA will be placed after 6 months After treatment a periapical radiograph and CBCT Planmeca Romexis Fenland will be immediately taken with ultra-low dose mode 90 kVp 56 mA 4 5 cm FOV and 02 vowel size to serve as the baseline with a reduced dose due to the need for future follow-ups
The CBCT will be performed using an ultralow dose small field of view and appropriate radiation protection as described by the American Association of Endodontics AAE and the American Academy of Oral and Maxillofacial Radiology AAOMR and the European Society of Endodontology guidelines
Shielding devices a leaded thyroid collar leaded glasses and a leaded apron will be used to protect the patients thyroid gland eye lens body respectively The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment Paracetamol will be prescribed if the patients had pain however no antibiotic will be used following the surgery The patients will receive a 3-month follow-up clinical and periapical radiographic examination together with 6 months clinical and CBCT examinations The clinical and radiograph evaluations will be performed by blinded experienced endodontist and radiologist The examiners will be trained in the evaluation criteria prior to the study To determine the reliability of the evaluations Kappa scores will be determined by the 2 examiners re-evaluating all cases 1 month after the initial evaluation performed The intra- and inter-examiner Kappa scores of the clinical evaluation will be 10 For the radiographic evaluation the intra-rater and inter-rater reliabilities will be 091 and 089 respectively When there will be a disagreement both examiners discussed the clinical and radiographic findings to achieve a consensus
Variables
Table 1 variables of the study
Variables Referring to Treatment agent MTA Nano propolis Nano curcumin
Time of assessment 6 months
Table 2 Interaction of variables of the study
Variables Test MTA Nano propolis Nano curcumin Total Clinical examination 18 18 18 54 Dentin bridge formation 18 18 18 54
Statistical Analysis
All data will be collected coded tabulated and statistically analyzed
1 Mineral trioxide aggregate MTA
2 Nano propolis
3 Nano curcumin
4 Glass ionomer
II Methods
Sample size calculation
Sample size calculation was performed using GPower version 3197 based on the results of a previous study The predicted sample size n was 54 ie 18 samples per group of the three groups to detect results of dentin bridge thickness
Sample preparation
Patients will be recruited from the department of Pediatric Dentistry and Dental Public Heath October 6 university The study sample will be recruited among the children between 7 to 13 years old The young permanent tooth eruption stage will be determined by the patients age and radiographic evaluation before enrolling in the research study
Before treatment a periapical radiograph will be taken with ultra-low dose mode to assess the tooth radiographically for any sign of irreversible pulpitis
Each tooth will be infiltrated with local anesthesia using 4 articaine with 1100000 epinephrine Septanest Septodont France The tooth will be isolated with a rubber dam and washed with 012 chlorhexidine The cavity will be prepared and the infected enamel and dentin will be removed with a round bur The carious dentin close to the pulp will be removed using a spoon excavator The pulp exposure position will be identified and the inflamed pulp tissue 15-2 mm will be gently removed using an abrasive diamond bur at high speed with copious sterilized normal saline The remaining healthy pulp will be rinsed with 25 sodium hypochlorite and moist sterilized cotton pellets will be placed over the pulp stumps with light pressure for 2 min to achieve hemostasis If the bleeding could not be controlled the tooth will be excluded from this study MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturers recommendation To cover the exposure area MTA and or nano propolis or nano curcumin will be placed using an amalgam carrier and non-toothed Adson forceps respectively The cavities will be lined with glass ionomer cement Vitrebond 3M ESPE St Paul MN USA and a permanent composite restoration Filtex Z350 3M ESPE Salt Lake City UT USA will be placed after 6 months After treatment a periapical radiograph and CBCT Planmeca Romexis Fenland will be immediately taken with ultra-low dose mode 90 kVp 56 mA 4 5 cm FOV and 02 vowel size to serve as the baseline with a reduced dose due to the need for future follow-ups
The CBCT will be performed using an ultralow dose small field of view and appropriate radiation protection as described by the American Association of Endodontics AAE and the American Academy of Oral and Maxillofacial Radiology AAOMR and the European Society of Endodontology guidelines
Shielding devices a leaded thyroid collar leaded glasses and a leaded apron will be used to protect the patients thyroid gland eye lens body respectively The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment Paracetamol will be prescribed if the patients had pain however no antibiotic will be used following the surgery The patients will receive a 3-month follow-up clinical and periapical radiographic examination together with 6 months clinical and CBCT examinations The clinical and radiograph evaluations will be performed by blinded experienced endodontist and radiologist The examiners will be trained in the evaluation criteria prior to the study To determine the reliability of the evaluations Kappa scores will be determined by the 2 examiners re-evaluating all cases 1 month after the initial evaluation performed The intra- and inter-examiner Kappa scores of the clinical evaluation will be 10 For the radiographic evaluation the intra-rater and inter-rater reliabilities will be 091 and 089 respectively When there will be a disagreement both examiners discussed the clinical and radiographic findings to achieve a consensus
Variables
Table 1 variables of the study
Variables Referring to Treatment agent MTA Nano propolis Nano curcumin
Time of assessment 6 months
Table 2 Interaction of variables of the study
Variables Test MTA Nano propolis Nano curcumin Total Clinical examination 18 18 18 54 Dentin bridge formation 18 18 18 54
Statistical Analysis
All data will be collected coded tabulated and statistically analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None