Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518629
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Photobiomodulation Before or After Tooth Whitening
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Photobiomodulation Before or After In-office Tooth Whitening for Sensitivity Reduction a Blinded Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The objective is to evaluate the effect of photobiomodulation PBM applied before or after in-office tooth whitening in reducing tooth sensitivity TS and color change Sixty-six patients aged between 18 and 28 years old of both sexes with good oral and general health will be selected for the study A randomization process will be carried out to allocate participants into the three different groups FBM-Before FBM-After and Placebo All groups will undergo in-office whitening treatment with 35 hydrogen peroxide Whitness HP FGM Joinville SC Brazil Three whitening sessions will be carried out considering a seven-day interval between sessions TS will be measured using a visual analogue scale VAS and a five-point numerical rating scale NRS while shade change will be assessed using a spectrophotometer before the bleaching treatment T0 after the first T1 second T2 and third T3 weeks of treatment and 30 days T4 after the end of the bleaching treatment
Detailed Description:
Ethical Considerations This research project will adhere to the recommendations of CONSORT Consolidated Standards of Reporting Trials Turner et al 2012 Participants will be fully informed about the risks methods and objectives of this study and their participation will require the signing of a free and informed consent form ICF in accordance with the Declaration of Helsinki World Medical Association 2013
All collected data will be used exclusively for scientific purposes and the identity of the participants will remain confidential Participation in the study may be withdrawn at any time and confidentiality will be assured even in the event of treatment discontinuation
Sample Size Calculation The sample size for this study was determined using GPower 31 Heinrich-Heine-Universität Düsseldorf Germany The calculation was based on a prior study by Moosavi et al 2016 which employed a methodology similar to that proposed in this investigation The sample size was calculated with a statistical power of 80 an alpha error of 5 and a predicted dropout rate of 20 The resulting sample size for this study is 22 patients per group
Study Design The clinical study will be a randomized parallel double-blind placebo-controlled trial Randomization will be performed to allocate participants into three different groups PBM-Before PBM-After and Placebo
All groups will undergo in-office whitening treatment with 35 hydrogen peroxide Whiteness HP FGM Joinville SC Brazil Three whitening sessions will be performed with a seven-day interval between sessions
Sample Selection A total of 66 patients aged 18 to 28 years of both genders with good general and oral health will be selected for the study The right maxillary canine must be classified as shade A2 or darker according to the Vita Classical shade guide VITA Zahnfabrik Bad Säckingen Germany
Individuals presenting with active caries or periodontal disease visible cracks in anterior teeth obvious malocclusion restorations or prosthetics in anterior teeth gastroesophageal disorders severe internal tooth discoloration due to tetracycline fluorosis or non-vital teeth dentin exposure in anterior or posterior teeth parafunctional habits dental sensitivity previous whitening treatment or orthodontic treatment will be excluded Additionally pregnant or breastfeeding individuals will not be included in this study
All participants will undergo prophylaxis using a rubber cup and pumice seven days prior to the start of the study and will receive oral hygiene kits to standardize the use of toothpaste without desensitizing agents
Randomization and Allocation Concealment A collaborator who will not participate in the clinical intervention stages of the study will be responsible for the randomization process Each participants clinical record will be stored in coded envelopes to maintain allocation concealment during randomization This process will be carried out using Random Allocation Software 100 University of Medical Sciences Isfahan Iran where an interval system will be generated for subject allocation into one of the three study groups
Blinding To ensure blinding of study participants efforts will be made to prevent them from seeing the light or hearing the sound of the laser device The sound emitted by the laser during light emission will be simulated using the iTalk Recorder app Griffin Technology Nashville Tennessee USA for iPhone 12 Apple Cupertino CA USA Pompeu et al 2021 In addition participants will wear headphones with a playlist to block any sound emitted by the laser device All participants will wear protective glasses provided by the manufacturer during the PBM sessions The operators will not be blinded as they will need to activate the laser when necessary However the evaluators will remain unaware of group allocation
Clinical Protocol
1 Photobiomodulation
Participants will receive treatment based on their allocated group
Placebo n22 Only in-office whitening will be performed Patients will not undergo additional treatments however a simulation of PBM application will be conducted before and after each whitening session The low-power laser Therapy EC DMC São Carlos SP Brazil will be positioned perpendicularly in contact with the cervical and apical regions of each tooth included in the whitening treatment During the simulation the device will not be activated meaning no irradiation will be applied
PBM-Before n22 Low-power laser therapy will be used immediately before the whitening session Energy of 4J will be delivered to each tooth using an infrared light IF at 808 nm 10 nm at two perpendicular points located in the apical and cervical regions on the buccal surface of the incisors canines and premolars The laser will operate in continuous mode and an energy of 2J will be applied at each point The protocol for treating dental sensitivity will follow the manufacturers recommendations Immediately after each whitening session a PBM simulation will be performed as described for the Placebo group
PBM-After n22 The low-power laser will be applied immediately after the whitening treatment The PBM protocol will be the same as described for the PBM-Before group The PBM simulation will occur before the whitening session begins as described for the Placebo group
2 Dental Whitening For the whitening treatment a gingival barrier will be placed using a light-curing resin Top Dam FGM Joinville SC Brazil followed by the application of a 35 hydrogen peroxide gel Whiteness HP FGM Joinville SC Brazil As per the manufacturers instructions three applications of the whitening gel will be made on the buccal surface of the incisors canines and premolars of both the upper and lower arches each lasting 15 minutes for a total of 45 minutes in each whitening session The whitening treatment will consist of three sessions with a seven-day interval between them
Post-Operative Sensitivity Assessment Participants will be instructed to complete a form Appendix I to record dental sensitivity based on individual pain perception This form will be provided after each whitening session and returned at the next appointment ie one week after each whitening session Participants will record the intensity of pain at the following time intervals 1 during the treatment 2 up to 1 hour after each whitening session 3 between 1 and 24 hours after each session 4 between 24 and 48 hours and 5 between 48 and 72 hours
Participants will receive detailed instructions on how to complete the form The evaluation form will include two pain scales a five-point numeric rating scale NRS and a visual analog scale VAS For the NRS participants will be asked to indicate a numerical value representing the degree of sensitivity where 0 means no sensitivity 1 mild 2 moderate 3 considerable and 4 severe sensitivity
For the VAS a 10 cm horizontal line with scores of 0 and 10 at each end will be used where 0 indicates no sensitivity and 10 indicates severe dental sensitivity Participants will be instructed to mark the intensity of dental sensitivity with a vertical line along the horizontal scale each day The distance in millimeters from the zero point will later be measured using a millimeter ruler to determine the level of pain intensity
Color Evaluation The same researcher responsible for the clinical intervention will perform the color evaluation at four time points baseline T0 one week after the first whitening session T1 one week after the second whitening session T2 and 30 days after the end of treatment T3 Color measurement will be performed using the VITA Easyshade spectrophotometer VITA Zahnfabrik Bad Säckingen Germany with the area of interest being the middle third of the buccal surface of the right maxillary canine
To standardize the color readings silicone guides Cub Kit Profle Vigodent will be fabricated For each canine a window will be created on the buccal surface of the silicone guide using a metallic device with a 6 mm radius matching the diameter of the spectrophotometer tip The devices tip will be inserted into the silicone guide to obtain the color parameters of the CIELab system where L represents lightness light or dark a measures red positive or green negative and b measures yellow positive or blue negative Commission Internationale De LEclairage 1978 The sum of the values measured for the upper canines will be used to calculate the average for each Lab coordinate for each patient ΔL Δa and Δb will be calculated as the difference between the time intervals The color difference between the baseline and the respective post-whitening time points will be calculated using the CIELab ΔEab74 and CIEDE2000 ΔE00 formulas Luo et al 2001 Della Bona et al 2019
All collected data will be used exclusively for scientific purposes and the identity of the participants will remain confidential Participation in the study may be withdrawn at any time and confidentiality will be assured even in the event of treatment discontinuation
Sample Size Calculation The sample size for this study was determined using GPower 31 Heinrich-Heine-Universität Düsseldorf Germany The calculation was based on a prior study by Moosavi et al 2016 which employed a methodology similar to that proposed in this investigation The sample size was calculated with a statistical power of 80 an alpha error of 5 and a predicted dropout rate of 20 The resulting sample size for this study is 22 patients per group
Study Design The clinical study will be a randomized parallel double-blind placebo-controlled trial Randomization will be performed to allocate participants into three different groups PBM-Before PBM-After and Placebo
All groups will undergo in-office whitening treatment with 35 hydrogen peroxide Whiteness HP FGM Joinville SC Brazil Three whitening sessions will be performed with a seven-day interval between sessions
Sample Selection A total of 66 patients aged 18 to 28 years of both genders with good general and oral health will be selected for the study The right maxillary canine must be classified as shade A2 or darker according to the Vita Classical shade guide VITA Zahnfabrik Bad Säckingen Germany
Individuals presenting with active caries or periodontal disease visible cracks in anterior teeth obvious malocclusion restorations or prosthetics in anterior teeth gastroesophageal disorders severe internal tooth discoloration due to tetracycline fluorosis or non-vital teeth dentin exposure in anterior or posterior teeth parafunctional habits dental sensitivity previous whitening treatment or orthodontic treatment will be excluded Additionally pregnant or breastfeeding individuals will not be included in this study
All participants will undergo prophylaxis using a rubber cup and pumice seven days prior to the start of the study and will receive oral hygiene kits to standardize the use of toothpaste without desensitizing agents
Randomization and Allocation Concealment A collaborator who will not participate in the clinical intervention stages of the study will be responsible for the randomization process Each participants clinical record will be stored in coded envelopes to maintain allocation concealment during randomization This process will be carried out using Random Allocation Software 100 University of Medical Sciences Isfahan Iran where an interval system will be generated for subject allocation into one of the three study groups
Blinding To ensure blinding of study participants efforts will be made to prevent them from seeing the light or hearing the sound of the laser device The sound emitted by the laser during light emission will be simulated using the iTalk Recorder app Griffin Technology Nashville Tennessee USA for iPhone 12 Apple Cupertino CA USA Pompeu et al 2021 In addition participants will wear headphones with a playlist to block any sound emitted by the laser device All participants will wear protective glasses provided by the manufacturer during the PBM sessions The operators will not be blinded as they will need to activate the laser when necessary However the evaluators will remain unaware of group allocation
Clinical Protocol
1 Photobiomodulation
Participants will receive treatment based on their allocated group
Placebo n22 Only in-office whitening will be performed Patients will not undergo additional treatments however a simulation of PBM application will be conducted before and after each whitening session The low-power laser Therapy EC DMC São Carlos SP Brazil will be positioned perpendicularly in contact with the cervical and apical regions of each tooth included in the whitening treatment During the simulation the device will not be activated meaning no irradiation will be applied
PBM-Before n22 Low-power laser therapy will be used immediately before the whitening session Energy of 4J will be delivered to each tooth using an infrared light IF at 808 nm 10 nm at two perpendicular points located in the apical and cervical regions on the buccal surface of the incisors canines and premolars The laser will operate in continuous mode and an energy of 2J will be applied at each point The protocol for treating dental sensitivity will follow the manufacturers recommendations Immediately after each whitening session a PBM simulation will be performed as described for the Placebo group
PBM-After n22 The low-power laser will be applied immediately after the whitening treatment The PBM protocol will be the same as described for the PBM-Before group The PBM simulation will occur before the whitening session begins as described for the Placebo group
2 Dental Whitening For the whitening treatment a gingival barrier will be placed using a light-curing resin Top Dam FGM Joinville SC Brazil followed by the application of a 35 hydrogen peroxide gel Whiteness HP FGM Joinville SC Brazil As per the manufacturers instructions three applications of the whitening gel will be made on the buccal surface of the incisors canines and premolars of both the upper and lower arches each lasting 15 minutes for a total of 45 minutes in each whitening session The whitening treatment will consist of three sessions with a seven-day interval between them
Post-Operative Sensitivity Assessment Participants will be instructed to complete a form Appendix I to record dental sensitivity based on individual pain perception This form will be provided after each whitening session and returned at the next appointment ie one week after each whitening session Participants will record the intensity of pain at the following time intervals 1 during the treatment 2 up to 1 hour after each whitening session 3 between 1 and 24 hours after each session 4 between 24 and 48 hours and 5 between 48 and 72 hours
Participants will receive detailed instructions on how to complete the form The evaluation form will include two pain scales a five-point numeric rating scale NRS and a visual analog scale VAS For the NRS participants will be asked to indicate a numerical value representing the degree of sensitivity where 0 means no sensitivity 1 mild 2 moderate 3 considerable and 4 severe sensitivity
For the VAS a 10 cm horizontal line with scores of 0 and 10 at each end will be used where 0 indicates no sensitivity and 10 indicates severe dental sensitivity Participants will be instructed to mark the intensity of dental sensitivity with a vertical line along the horizontal scale each day The distance in millimeters from the zero point will later be measured using a millimeter ruler to determine the level of pain intensity
Color Evaluation The same researcher responsible for the clinical intervention will perform the color evaluation at four time points baseline T0 one week after the first whitening session T1 one week after the second whitening session T2 and 30 days after the end of treatment T3 Color measurement will be performed using the VITA Easyshade spectrophotometer VITA Zahnfabrik Bad Säckingen Germany with the area of interest being the middle third of the buccal surface of the right maxillary canine
To standardize the color readings silicone guides Cub Kit Profle Vigodent will be fabricated For each canine a window will be created on the buccal surface of the silicone guide using a metallic device with a 6 mm radius matching the diameter of the spectrophotometer tip The devices tip will be inserted into the silicone guide to obtain the color parameters of the CIELab system where L represents lightness light or dark a measures red positive or green negative and b measures yellow positive or blue negative Commission Internationale De LEclairage 1978 The sum of the values measured for the upper canines will be used to calculate the average for each Lab coordinate for each patient ΔL Δa and Δb will be calculated as the difference between the time intervals The color difference between the baseline and the respective post-whitening time points will be calculated using the CIELab ΔEab74 and CIEDE2000 ΔE00 formulas Luo et al 2001 Della Bona et al 2019
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