Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183021
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-12-13
Brief Title:
The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
The Effect of Cryotherapy on the Outcome of Pulpotomy and Root Canal Treatment of Deep Dentinal Caries a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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 goal of this randomized clinical trial is to compare the outcome of total amputation and root canal treatment with or without cryotherapy in terms of postoperative pain quality of life and treatment success for the management of deep dentinal caries The main questions it aims to answer are
Does cryotherapy influence the outcome life quality and treatment success in total pulpotomy Does cryotherapy influence the outcome life quality and treatment success in root canal treatment Does the outcome of total pulpotomy and root canal treatment differ in cases of pulpitis
There are 4 experimental groups
1 Total pulpotomy with cryotherapy group
2 Total pulpotomy group Control 1
3 Root canal treatment with cryotherapy group
4 Root canal treatment group Control 2
Does cryotherapy influence the outcome life quality and treatment success in total pulpotomy Does cryotherapy influence the outcome life quality and treatment success in root canal treatment Does the outcome of total pulpotomy and root canal treatment differ in cases of pulpitis
There are 4 experimental groups
1 Total pulpotomy with cryotherapy group
2 Total pulpotomy group Control 1
3 Root canal treatment with cryotherapy group
4 Root canal treatment group Control 2
Detailed Description:
Sample Size Determination Method and Total Number of Subjects for the Study
The study will span 24 months and a total of 144 patients meeting the inclusion criteria will be selected from those seeking treatment at the Endodontics clinic of Ondokuz Mayıs University Faculty of Dentistry
An a priori power analysis was performed using the treatment success rate parameter under the Survival Analysis Comparison of Two Survival Curves - Lachin section at the link Survival Analysis Comparison of Two Survival Curves - Lachin Based on the treatment success rates in the study by Asgary et al 2015 - 761 for vital pulp therapy and 756 for root canal treatment with a type I error of 005 and a beta value of 095 a minimum sample size of 30 per group was calculated Considering a 20 follow-up loss 36 subjects per group will be included n 36
Patients within the age range of 18-65 systemically healthy with upper and lower jaw molars deep dentin caries and no known allergies to materials and drugs used in root canal treatment will be assessed for inclusion criteria in the endodontics clinic Pulp sensitivity tests using cold and electric pulp tests will be conducted If the pulp chamber does not become exposed after caries removal or if necrosis is detected in at least one canal with no bleeding after cavity preparation the voluntary participant will be excluded from the study and appropriate treatment will be completed Radiological examination will evaluate the presence of radiolucent lesions in periapical areas using periapical radiographs taken from different angles Teeth with a periapical index value greater than 1 indicating radiolucency observed in apical periodontitis will be excluded Orstavik 1986 Teeth that cannot be isolated with a rubber dam for which coronal obturation cannot be achieved teeth with fractures advanced periodontal disease and teeth with multiple lost cavity walls will be excluded from the study
Before starting the treatment patients will randomly select one of four sealed envelopes containing the name of the study group The envelope will be sealed until the randomization phase before cavity preparation after local anaesthesia and isolation to ensure that the operator remains unaware of the study group name Patients will be informed about the visual analogue scale VAS and quality of life scales related to oral health before the treatment
Preparation and Disinfection for Treatment
The tooth will be isolated with a rubber dam after local anaesthesia administration 20 mL adrenaline 1100000 4 articaine Following isolation the coronal surfaces of the tooth will be sequentially disinfected with 3 hydrogen peroxide and 525 sodium hypochlorite The investigator will perform all operative procedures under 35x magnification using loupes available in our clinic
Number and Names of Groups in the Study
Total Coronal Amputation Cryotherapy and Control Groups
In this group the coronal pulp exposed after caries removal will be completely removed with a sterile steel round bur In the cryotherapy subgroup the cavity surface will be treated with 1 minute of grated sterile ice applied according to the protocol described by Bahcall et al 2019 and removed with a melting water absorbent The pulp chamber will be irrigated in both groups with 17 ethylenediaminetetraacetic acid EDTA for 1 minute Subsequently the pulp chamber will be restored with a composite resin over a Biodentine-prepared cavity using light-cured composite resin If bleeding persists for more than 5 minutes in the pulp chamber the participant will be excluded and root canal treatment will be completed
Root Canal Treatment Cryotherapy and Control Groups
After cleaning the caries an appropriate endodontic access cavity will be prepared Using a size 10-15 K-type hand file with an apex locator canal shaping will be performed with the TruNatomy file system After each change preserving apical patency will be ensured with a size 10-15 K-type file After preparation the canals will be irrigated sequentially with 5 mL of 17 EDTA distilled water and 525 sodium hypochlorite
In the control group the EndoVac negative-pressure irrigation system will be used to irrigate with 20 mL of distilled water stored at room temperature for 5 minutes In the cryotherapy group the same irrigation system will be used to irrigate with 20 mL of distilled water stored at 25C in the refrigerator for 5 minutes Temperature control will be ensured during irrigation using thermocouples and a thermometer The canals will then be dried with sterile paper points and filled with AH Plus Bioceramic and gutta-percha points Coronal restorations will be performed with light-cured composite resin and bond adhesive
The study will span 24 months and a total of 144 patients meeting the inclusion criteria will be selected from those seeking treatment at the Endodontics clinic of Ondokuz Mayıs University Faculty of Dentistry
An a priori power analysis was performed using the treatment success rate parameter under the Survival Analysis Comparison of Two Survival Curves - Lachin section at the link Survival Analysis Comparison of Two Survival Curves - Lachin Based on the treatment success rates in the study by Asgary et al 2015 - 761 for vital pulp therapy and 756 for root canal treatment with a type I error of 005 and a beta value of 095 a minimum sample size of 30 per group was calculated Considering a 20 follow-up loss 36 subjects per group will be included n 36
Patients within the age range of 18-65 systemically healthy with upper and lower jaw molars deep dentin caries and no known allergies to materials and drugs used in root canal treatment will be assessed for inclusion criteria in the endodontics clinic Pulp sensitivity tests using cold and electric pulp tests will be conducted If the pulp chamber does not become exposed after caries removal or if necrosis is detected in at least one canal with no bleeding after cavity preparation the voluntary participant will be excluded from the study and appropriate treatment will be completed Radiological examination will evaluate the presence of radiolucent lesions in periapical areas using periapical radiographs taken from different angles Teeth with a periapical index value greater than 1 indicating radiolucency observed in apical periodontitis will be excluded Orstavik 1986 Teeth that cannot be isolated with a rubber dam for which coronal obturation cannot be achieved teeth with fractures advanced periodontal disease and teeth with multiple lost cavity walls will be excluded from the study
Before starting the treatment patients will randomly select one of four sealed envelopes containing the name of the study group The envelope will be sealed until the randomization phase before cavity preparation after local anaesthesia and isolation to ensure that the operator remains unaware of the study group name Patients will be informed about the visual analogue scale VAS and quality of life scales related to oral health before the treatment
Preparation and Disinfection for Treatment
The tooth will be isolated with a rubber dam after local anaesthesia administration 20 mL adrenaline 1100000 4 articaine Following isolation the coronal surfaces of the tooth will be sequentially disinfected with 3 hydrogen peroxide and 525 sodium hypochlorite The investigator will perform all operative procedures under 35x magnification using loupes available in our clinic
Number and Names of Groups in the Study
Total Coronal Amputation Cryotherapy and Control Groups
In this group the coronal pulp exposed after caries removal will be completely removed with a sterile steel round bur In the cryotherapy subgroup the cavity surface will be treated with 1 minute of grated sterile ice applied according to the protocol described by Bahcall et al 2019 and removed with a melting water absorbent The pulp chamber will be irrigated in both groups with 17 ethylenediaminetetraacetic acid EDTA for 1 minute Subsequently the pulp chamber will be restored with a composite resin over a Biodentine-prepared cavity using light-cured composite resin If bleeding persists for more than 5 minutes in the pulp chamber the participant will be excluded and root canal treatment will be completed
Root Canal Treatment Cryotherapy and Control Groups
After cleaning the caries an appropriate endodontic access cavity will be prepared Using a size 10-15 K-type hand file with an apex locator canal shaping will be performed with the TruNatomy file system After each change preserving apical patency will be ensured with a size 10-15 K-type file After preparation the canals will be irrigated sequentially with 5 mL of 17 EDTA distilled water and 525 sodium hypochlorite
In the control group the EndoVac negative-pressure irrigation system will be used to irrigate with 20 mL of distilled water stored at room temperature for 5 minutes In the cryotherapy group the same irrigation system will be used to irrigate with 20 mL of distilled water stored at 25C in the refrigerator for 5 minutes Temperature control will be ensured during irrigation using thermocouples and a thermometer The canals will then be dried with sterile paper points and filled with AH Plus Bioceramic and gutta-percha points Coronal restorations will be performed with light-cured composite resin and bond adhesive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None