Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553144
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Comparative Analysis of Photodynamic Therapy on Periapical Healing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Analysis of Intra-canal Photodynamic Therapy With Different Photosensitizers on Periapical Healing
Status:
COMPLETED
Status Verified Date:
2024-08
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:
As a result of tooth decay lesions caused by infection occur at the root tip These teeth can heal with root canal treatment In this study additional applications will be made to increase the success of root canal treatment The materials we will use are harmless At the end of the procedure your teeth will be monitored regularly and their healing status will be checked
Detailed Description:
Root canal therapy seeks to eradicate root canal infections and prevent their recurrence Given the intricate nature of the root canal system and biofilm formations achieving complete disinfection with current techniques is challenging Nevertheless it has been noted that residual microorganisms within the root canal contribute significantly to either the healing or the development of apical periodontitis Various methods such as sonic and ultrasonic activation laser application and PDT Photodynamic Therapy have been proposed in literature to enhance root canal disinfection
Several in vivo and in vitro studies have demonstrated a significant reduction in bacterial load following PDT adjunct to root canal therapy However long-term in vivo outcomes of PDT as a complement to root canal disinfection remain scarce From an endodontic perspective many photosensitizers have not undergone clinical evaluation This study seeks to assess the impact of PDT using different photosensitizers on in vivo lesion healing
First of all teeth that met the inclusion criteria were planned to be randomly divided into 4 groups However in this case gender and tooth numbers would not be distributed equally among the groups Therefore a stratified randomization method was employed to ensure balanced distribution of participants across the four study groups based on gender male female and tooth type anterior premolar To ensure an unbiased distribution of teeth across four treatment groups Curcumin Methylene Blue Erythrosine B and Control a randomization process was implemented using Excel VBA Visual Basic for Applications by a third party not involved in the study intervention
Vitality tests yielded negative results for all teeth The treatments were administered consistently by the same operator to ensure uniformity However due to irregular attendance at follow-up appointments by six patients and one instance of tooth extraction the study ultimately involved 70 teeth as elaborated in Study Design Participants were randomized into four groups Periapical radiographs of the teeth were captured using a dental X-ray unit Satalect X-Mind France set at 250 kV 4 mA and 012 seconds of irradiation time employing a parallel technique guided by a cone indicator For teeth with indistinct lesion sizes on periapical radiographs three-dimensional images were acquired using cone beam computed tomography CBCT Planmeca Helsinki Finland with settings of 90 kVp 12 mA 14 seconds and a 16x5 imaging field
Following rubber dam isolation access cavities were prepared using a diamond bur The working length was determined using a 15 K-file Dentsply Maillefer Ballaigues Switzerland coupled with an apex locator Root ZX Morita Japan ensuring a 05 mm short of the 340034 point Radiographic confirmation of the working length was obtained
Canal instrumentation up to a 20 K-file was carried out followed by further preparation using the R25 Reciproc instrument VDW Munich Germany operated by a VDW Silver endodontic motor VDW at the Reciproc All setting After three pecking motions irrigation with 5 Sodium hypochlorite NaOCl Werax İzmir Türkiye was conducted until the full canal length was reached Mechanical instrumentation is completed with the R40 instrument
Throughout the procedure each canal received irrigation with 10 mL of 5 NaOCl at a flow rate of 01 mlsec via a 30-G irrigation needle Endo-Top Wola Poland positioned 1 mm short of the working length Subsequently canals were rinsed with distilled water and then irrigated with 5 mL of 17 EDTA Kemiger Ankara Turkey for 1 minute allowing an additional 1-minute dwell time Ultrasonic activation involved using 2 mL of NaOCl in total administered three times for 20 seconds each employing a Niti U-File 25 attached to the E2 tip of an ultrasonic device Woodpecker China in endodontic mode positioned 1 mm short of the working length After each irrigation step canals were rinsed with distilled water
Following this stage participants were allocated into four groups for the final irrigation protocol The randomization process determined which protocol would be performed for each tooth and was performed by a blinded assistant
Group 1 A curcumin solution was prepared by dissolving curcumin Sigma-Aldrich Steinheim Germany in 05 dimethyl sulfoxide DMSO Aromel Medikal Konya Türkiye to achieve a final concentration of 50 mgmL The photosensitizer was delivered into the canal using an irrigation needle until the pulp chamber was filled After a 3-minute wait ultrasonic activation was performed for 20 seconds The solution was then refreshed and the activation process was repeated two more times for a total of 60 seconds The last refreshed photosensitizer was irradiated with a 200mW diode laser SiroLaser Blue Dentsply Germany at a wavelength of 450 nm employing spiral movements with an EasyTip 200 µm Endo fiber optic tip for 20 seconds This process was repeated two more times Finally the photosensitizer was rinsed with distilled water
Group 2 Erythrosine B Sigma Aldrich St Louis MO USA was diluted with phosphate-buffered saline solution to achieve a final concentration of 03 mgmL Ultrasonic activation was performed similarly to Group 1 but laser application utilized a wavelength of 660 nm and a power of 100 mW
Group 3 Methylene blue Sigma-Aldrich Germany at a concentration of 01 mgmL was introduced into the canal as in the previous groups and activated by both ultrasonic and laser methods The parameters for this group were also set to a wavelength of 660 nm and a power of 100 mW
Group 4 Canals were irrigated with 10 mL of 5 NaOCl at a flow rate of 01 mLsec
All canals were subsequently rinsed with distilled water The final irrigation involved the use of 2 mL of 1 EDTA for 1 minute A 4004 master gutta-percha cone was placed and confirmed radiographically Canals were dried using sterile paper points The obturation of canals with the 4004 gutta-percha cones was carried out using Endoplus PresidentMünchen Germany and the lateral condensation technique Following the removal of excess gutta-percha access cavities were cleaned with alcohol and restored incrementally with resin-modified glass ionomer cement Riva Light Cure HV Australia and composite resin G-Premio Bond Tokyo Japan
Participants were scheduled for follow-up appointments at 6 12 and 24 hours as well as at 1 week during which they were asked to report any pain experienced Pain levels were assessed using the Visual Analogue Scale VAS ranging from 0 no pain to 10 most severe pain and recorded accordingly Subsequent follow-up appointments were scheduled at 1 3 6 and 9 months and a final 1-year follow-up during which radiographs were taken to monitor the healing of the lesions
Several in vivo and in vitro studies have demonstrated a significant reduction in bacterial load following PDT adjunct to root canal therapy However long-term in vivo outcomes of PDT as a complement to root canal disinfection remain scarce From an endodontic perspective many photosensitizers have not undergone clinical evaluation This study seeks to assess the impact of PDT using different photosensitizers on in vivo lesion healing
First of all teeth that met the inclusion criteria were planned to be randomly divided into 4 groups However in this case gender and tooth numbers would not be distributed equally among the groups Therefore a stratified randomization method was employed to ensure balanced distribution of participants across the four study groups based on gender male female and tooth type anterior premolar To ensure an unbiased distribution of teeth across four treatment groups Curcumin Methylene Blue Erythrosine B and Control a randomization process was implemented using Excel VBA Visual Basic for Applications by a third party not involved in the study intervention
Vitality tests yielded negative results for all teeth The treatments were administered consistently by the same operator to ensure uniformity However due to irregular attendance at follow-up appointments by six patients and one instance of tooth extraction the study ultimately involved 70 teeth as elaborated in Study Design Participants were randomized into four groups Periapical radiographs of the teeth were captured using a dental X-ray unit Satalect X-Mind France set at 250 kV 4 mA and 012 seconds of irradiation time employing a parallel technique guided by a cone indicator For teeth with indistinct lesion sizes on periapical radiographs three-dimensional images were acquired using cone beam computed tomography CBCT Planmeca Helsinki Finland with settings of 90 kVp 12 mA 14 seconds and a 16x5 imaging field
Following rubber dam isolation access cavities were prepared using a diamond bur The working length was determined using a 15 K-file Dentsply Maillefer Ballaigues Switzerland coupled with an apex locator Root ZX Morita Japan ensuring a 05 mm short of the 340034 point Radiographic confirmation of the working length was obtained
Canal instrumentation up to a 20 K-file was carried out followed by further preparation using the R25 Reciproc instrument VDW Munich Germany operated by a VDW Silver endodontic motor VDW at the Reciproc All setting After three pecking motions irrigation with 5 Sodium hypochlorite NaOCl Werax İzmir Türkiye was conducted until the full canal length was reached Mechanical instrumentation is completed with the R40 instrument
Throughout the procedure each canal received irrigation with 10 mL of 5 NaOCl at a flow rate of 01 mlsec via a 30-G irrigation needle Endo-Top Wola Poland positioned 1 mm short of the working length Subsequently canals were rinsed with distilled water and then irrigated with 5 mL of 17 EDTA Kemiger Ankara Turkey for 1 minute allowing an additional 1-minute dwell time Ultrasonic activation involved using 2 mL of NaOCl in total administered three times for 20 seconds each employing a Niti U-File 25 attached to the E2 tip of an ultrasonic device Woodpecker China in endodontic mode positioned 1 mm short of the working length After each irrigation step canals were rinsed with distilled water
Following this stage participants were allocated into four groups for the final irrigation protocol The randomization process determined which protocol would be performed for each tooth and was performed by a blinded assistant
Group 1 A curcumin solution was prepared by dissolving curcumin Sigma-Aldrich Steinheim Germany in 05 dimethyl sulfoxide DMSO Aromel Medikal Konya Türkiye to achieve a final concentration of 50 mgmL The photosensitizer was delivered into the canal using an irrigation needle until the pulp chamber was filled After a 3-minute wait ultrasonic activation was performed for 20 seconds The solution was then refreshed and the activation process was repeated two more times for a total of 60 seconds The last refreshed photosensitizer was irradiated with a 200mW diode laser SiroLaser Blue Dentsply Germany at a wavelength of 450 nm employing spiral movements with an EasyTip 200 µm Endo fiber optic tip for 20 seconds This process was repeated two more times Finally the photosensitizer was rinsed with distilled water
Group 2 Erythrosine B Sigma Aldrich St Louis MO USA was diluted with phosphate-buffered saline solution to achieve a final concentration of 03 mgmL Ultrasonic activation was performed similarly to Group 1 but laser application utilized a wavelength of 660 nm and a power of 100 mW
Group 3 Methylene blue Sigma-Aldrich Germany at a concentration of 01 mgmL was introduced into the canal as in the previous groups and activated by both ultrasonic and laser methods The parameters for this group were also set to a wavelength of 660 nm and a power of 100 mW
Group 4 Canals were irrigated with 10 mL of 5 NaOCl at a flow rate of 01 mLsec
All canals were subsequently rinsed with distilled water The final irrigation involved the use of 2 mL of 1 EDTA for 1 minute A 4004 master gutta-percha cone was placed and confirmed radiographically Canals were dried using sterile paper points The obturation of canals with the 4004 gutta-percha cones was carried out using Endoplus PresidentMünchen Germany and the lateral condensation technique Following the removal of excess gutta-percha access cavities were cleaned with alcohol and restored incrementally with resin-modified glass ionomer cement Riva Light Cure HV Australia and composite resin G-Premio Bond Tokyo Japan
Participants were scheduled for follow-up appointments at 6 12 and 24 hours as well as at 1 week during which they were asked to report any pain experienced Pain levels were assessed using the Visual Analogue Scale VAS ranging from 0 no pain to 10 most severe pain and recorded accordingly Subsequent follow-up appointments were scheduled at 1 3 6 and 9 months and a final 1-year follow-up during which radiographs were taken to monitor the healing of the lesions
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