Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599814
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment in Permanent Molars
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Evaluation of the Clinical Outcome of Direct Pulp Capping Treatment Using Bioactive Materials With Diode Laser in Permanent Molars a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will be performed during June 2024 and December 2024 The study is conducted following the Declaration of Helsinki Ethical principles for medical research involving human subjects after being independently reviewed and approved by the Institutions Ethical Committee and is designed in accordance with CONSORT 2010
Selected patients who are between 19 and 40 years of age had undergone conservative treatment for deep caries management in their permanent teeth in the restorative and endodontic departments faculty of dentistry Kafrelsheikh university The patients are then assigned randomly into four different groups for this randomized clinical study The decision for direct pulp capping will be made after informing the patients about all the pulp capping procedures that are suggested Furthermore any possible complications postoperative discomfort or failure of the treatment will be discussed with the patient All included patients signed a written informed consent before enrollment
Selected patients who are between 19 and 40 years of age had undergone conservative treatment for deep caries management in their permanent teeth in the restorative and endodontic departments faculty of dentistry Kafrelsheikh university The patients are then assigned randomly into four different groups for this randomized clinical study The decision for direct pulp capping will be made after informing the patients about all the pulp capping procedures that are suggested Furthermore any possible complications postoperative discomfort or failure of the treatment will be discussed with the patient All included patients signed a written informed consent before enrollment
Detailed Description:
A total of 120 posterior teeth from 60 patients are randomly divided into 4 groups according to the type of treatment RetroMTA Conventional group TheraCal Conventional group RetroMTA laser group and TheraCal laser group n 30
A checklist is created for each patient following their selection and completion of the consent form periapical radiography is carried out and coldheat tests to confirm the vitality of the teeth Mouth rinsing is done with 02 chlorhexidine oral rinse for 1 minute All of the patients teeth are treated by the same dentist In all groups if the bleeding persisted for longer than three minutes following pulp exposure would be eliminated from the research
Clinical procedures Following local anesthetic the teeth are suitably isolated under a rubber dam and the caries is removed using the appropriate hand and rotating equipment There will have been tooth cleaning and bleeding control using cotton pellets lightly moistened with sterile saline applied to the exposed site Patients are randomly divided into two techniques a conventional technique that acts as a control group in which laser is not used and a laser-assisted technique in which Diode laser is applied before application of pulp capping materials The patients are allocated into one of the following groups RetroMTA Conventional group TheraCal Conventional group RetroMTA laser group and TheraCal laser group
Conventional Technique control group RetroMTA Conventional group n 30 After controlling the bleeding RetroMTA is mixed with the supplied liquid at a WP ratio of 3 drops per 03 g After 150 seconds selective etching application of adhesive material and application of resin composite restorations will occur according to the manufacturers instructions
TheraCal Conventional group n 30 Subsequent to controlling the bleeding using a needle-tip syringe gently apply TheraCal LC resin-modified calcium silicate Bisco Inc Schamburg IL USA light-hardening paste to the exposed portion of the pulp in accordance with the manufacturers recommendations for thickness 1 mm and curing time 20 Seconds
Laser-assisted technique Consequent to controlling the bleeding Diode laser is focused to the exposure sites before the placement of pulp capping materials The protective goggles for the patient operator and assistant are checked The hemostasis is obtained by the diode 808-nm laser-assisted procedure Picasso-AMD USA using 15 W continuous wave fiber diameter of 400 μm non-initiated and in contact mode tip angle set at 90 beam divergence 16 2 s per an area with 1-mm diameter power density 19098 Wcm2 energy density 38197 Jcm2 and vertical and horizontal scanning movement on the exposure site Decontamination of the cavity is performed by 1 W continuous wave fiber diameter of 400 μm non-initiated and in contact mode tip angle set at 90 an area with 2-mm diameter per second power density 3183 Wcm2 energy density 3183 Jcm2 per second and circular movement The use of diode laser will be used for 1 to 3 seconds Following to laser application the pulp capping materials either RetroMTA or TheraCal are placed over the exposure site according to the randomization protocol
TheraCal laser group n 30 Application of TheraCal are occurred as TheraCal Conventional group RetroMTA laser group n 30 Application of RetroMTA are occurred as RetroMTA Conventional group Restorative procedures The cavities are permanently restored at the same session using universal Adhesive in selective etch technique for enamel margins and self-etch for cavities dentine following a layer of flowable and then nanohybrid composite
Follow-Up and Evaluation of the Success At each recall examination 1 3 and 6 months the information obtained from clinical and radiographic examinations is recorded in a special form Clinical assessments are performed by applying ice on the buccal side percussion test to forecast the periradicular involvement of the tooth and palpation test to forecast the extent of periradicular bone involvement In addition follow up of the postoperative pain will be occurred The clinical failure criteria included the loss of vitality spontaneous pain prolonged reactions to thermal stimuli and tenderness to percussion
Radiographic assessments are performed by a calibrated endodontist who is also blind to the type of treatment groups Every digital radiograph is examined for dentin formation periapical and furcal radiolucency expansion of the periodontal ligament space and any pulpal calcifications After that every radiograph is scanned and uploaded to the computer for digital analysis Measurements on the digitized radiographs are performed in the first third and sixth months The increase in dentin thickness is thus measured using Image J program Microsoft Corp Washington Redmond USA The statistical analyses based on the repeated measurements ANOVA are conducted for selected data sets
A checklist is created for each patient following their selection and completion of the consent form periapical radiography is carried out and coldheat tests to confirm the vitality of the teeth Mouth rinsing is done with 02 chlorhexidine oral rinse for 1 minute All of the patients teeth are treated by the same dentist In all groups if the bleeding persisted for longer than three minutes following pulp exposure would be eliminated from the research
Clinical procedures Following local anesthetic the teeth are suitably isolated under a rubber dam and the caries is removed using the appropriate hand and rotating equipment There will have been tooth cleaning and bleeding control using cotton pellets lightly moistened with sterile saline applied to the exposed site Patients are randomly divided into two techniques a conventional technique that acts as a control group in which laser is not used and a laser-assisted technique in which Diode laser is applied before application of pulp capping materials The patients are allocated into one of the following groups RetroMTA Conventional group TheraCal Conventional group RetroMTA laser group and TheraCal laser group
Conventional Technique control group RetroMTA Conventional group n 30 After controlling the bleeding RetroMTA is mixed with the supplied liquid at a WP ratio of 3 drops per 03 g After 150 seconds selective etching application of adhesive material and application of resin composite restorations will occur according to the manufacturers instructions
TheraCal Conventional group n 30 Subsequent to controlling the bleeding using a needle-tip syringe gently apply TheraCal LC resin-modified calcium silicate Bisco Inc Schamburg IL USA light-hardening paste to the exposed portion of the pulp in accordance with the manufacturers recommendations for thickness 1 mm and curing time 20 Seconds
Laser-assisted technique Consequent to controlling the bleeding Diode laser is focused to the exposure sites before the placement of pulp capping materials The protective goggles for the patient operator and assistant are checked The hemostasis is obtained by the diode 808-nm laser-assisted procedure Picasso-AMD USA using 15 W continuous wave fiber diameter of 400 μm non-initiated and in contact mode tip angle set at 90 beam divergence 16 2 s per an area with 1-mm diameter power density 19098 Wcm2 energy density 38197 Jcm2 and vertical and horizontal scanning movement on the exposure site Decontamination of the cavity is performed by 1 W continuous wave fiber diameter of 400 μm non-initiated and in contact mode tip angle set at 90 an area with 2-mm diameter per second power density 3183 Wcm2 energy density 3183 Jcm2 per second and circular movement The use of diode laser will be used for 1 to 3 seconds Following to laser application the pulp capping materials either RetroMTA or TheraCal are placed over the exposure site according to the randomization protocol
TheraCal laser group n 30 Application of TheraCal are occurred as TheraCal Conventional group RetroMTA laser group n 30 Application of RetroMTA are occurred as RetroMTA Conventional group Restorative procedures The cavities are permanently restored at the same session using universal Adhesive in selective etch technique for enamel margins and self-etch for cavities dentine following a layer of flowable and then nanohybrid composite
Follow-Up and Evaluation of the Success At each recall examination 1 3 and 6 months the information obtained from clinical and radiographic examinations is recorded in a special form Clinical assessments are performed by applying ice on the buccal side percussion test to forecast the periradicular involvement of the tooth and palpation test to forecast the extent of periradicular bone involvement In addition follow up of the postoperative pain will be occurred The clinical failure criteria included the loss of vitality spontaneous pain prolonged reactions to thermal stimuli and tenderness to percussion
Radiographic assessments are performed by a calibrated endodontist who is also blind to the type of treatment groups Every digital radiograph is examined for dentin formation periapical and furcal radiolucency expansion of the periodontal ligament space and any pulpal calcifications After that every radiograph is scanned and uploaded to the computer for digital analysis Measurements on the digitized radiographs are performed in the first third and sixth months The increase in dentin thickness is thus measured using Image J program Microsoft Corp Washington Redmond USA The statistical analyses based on the repeated measurements ANOVA are conducted for selected data sets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None