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Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.
The experimental design will follow the consolidated standards for test reports (CONSORT). After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal Fluminense University located in Nova Friburgo.Every Health Institute participants will be informed about the nature and objectives of the study.It will be one test study Clinical randomized, parallel, triple-blind, used to measure the level of tooth sensitivity volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention. |
|
| Placebo | Placebo Comparator | 35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone acetate | Drug | The volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogic Scale (0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | One hour |
| Visual Analogic Scale(0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | Twenty four hours |
| Visual Analogic Scale(0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | Forty eight hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcos O Barceleiro, MSD, PhD | Fluminense Federal University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24929591 | Background | Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13. | |
| 23371755 | Background | de Paula EA, Loguercio AD, Fernandes D, Kossatz S, Reis A. Perioperative use of an anti-inflammatory drug on tooth sensitivity caused by in-office bleaching: a randomized, triple-blind clinical trial. Clin Oral Investig. 2013 Dec;17(9):2091-7. doi: 10.1007/s00784-013-0918-2. Epub 2013 Jan 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | 35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in the Dexamethasone acetate group (experimental group) received six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied w |
| FG001 | Placebo | 35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | 35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogic Scale (0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | Posted | Mean | Standard Deviation | units on a scale | One hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | 35 patients in this group underwent the whitening procedure using the Dexamethasone acetate intervention. Dexamethasone acetate: The volunteers in this group received 6 capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg 9 am to 1 day before session whitening, 8 mg 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo was applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
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No discontinuity in both treatment groups was found in the clinical investigation. All volunteers attended the recall visit 1 week postbleaching.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luiz Augusto Poubel | Universidade Federal Fluminense | 55 21 981113344 | luizpoubel@id.uff.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Aug 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C018038 | dexamethasone acetate |
| D003907 | Dexamethasone |
| C023844 | potassium nitrate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Potassium Nitrate | Drug | The volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
|
|
| 23802640 | Background | de Paula EA, Kossatz S, Fernandes D, Loguercio AD, Reis A. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial. Oper Dent. 2014 Mar-Apr;39(2):128-35. doi: 10.2341/12-483-C. Epub 2013 Jun 26. |
| 25257824 | Background | de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23. |
| 23959376 | Background | Bonafe E, Loguercio AD, Reis A, Kossatz S. Effectiveness of a desensitizing agent before in-office tooth bleaching in restored teeth. Clin Oral Investig. 2014 Apr;18(3):839-45. doi: 10.1007/s00784-013-1055-7. |
| 23357647 | Background | Bonafe E, Bacovis CL, Iensen S, Loguercio AD, Reis A, Kossatz S. Tooth sensitivity and efficacy of in-office bleaching in restored teeth. J Dent. 2013 Apr;41(4):363-9. doi: 10.1016/j.jdent.2013.01.007. Epub 2013 Jan 26. |
| 25637206 | Background | Faria-E-Silva AL, Nahsan FP, Fernandes MT, Martins-Filho PR. Effect of preventive use of nonsteroidal anti-inflammatory drugs on sensitivity after dental bleaching: a systematic review and meta-analysis. J Am Dent Assoc. 2015 Feb;146(2):87-93.e1. doi: 10.1016/j.adaj.2014.10.007. |
| 22525016 | Background | He LB, Shao MY, Tan K, Xu X, Li JY. The effects of light on bleaching and tooth sensitivity during in-office vital bleaching: a systematic review and meta-analysis. J Dent. 2012 Aug;40(8):644-53. doi: 10.1016/j.jdent.2012.04.010. Epub 2012 Apr 21. |
| 24872720 | Background | Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014. |
| 23846062 | Background | Li Y, Greenwall L. Safety issues of tooth whitening using peroxide-based materials. Br Dent J. 2013 Jul;215(1):29-34. doi: 10.1038/sj.bdj.2013.629. |
| 20045265 | Background | Markowitz K. Pretty painful: why does tooth bleaching hurt? Med Hypotheses. 2010 May;74(5):835-40. doi: 10.1016/j.mehy.2009.11.044. Epub 2009 Dec 31. |
| 20303048 | Background | Costa CA, Riehl H, Kina JF, Sacono NT, Hebling J. Human pulp responses to in-office tooth bleaching. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):e59-64. doi: 10.1016/j.tripleo.2009.12.002. |
| 16236742 | Background | Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available. |
| 16274480 | Background | Bamgbose BO, Akinwande JA, Adeyemo WL, Ladeinde AL, Arotiba GT, Ogunlewe MO. Effects of co-administered dexamethasone and diclofenac potassium on pain, swelling and trismus following third molar surgery. Head Face Med. 2005 Nov 7;1:11. doi: 10.1186/1746-160X-1-11. |
| 23586657 | Background | Paula E, Kossatz S, Fernandes D, Loguercio A, Reis A. The effect of perioperative ibuprofen use on tooth sensitivity caused by in-office bleaching. Oper Dent. 2013 Nov-Dec;38(6):601-8. doi: 10.2341/12-107-C. Epub 2013 Apr 15. |
| 21913864 | Background | Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent. 2011 Nov-Dec;36(6):590-6. doi: 10.2341/10-173-C. Epub 2011 Sep 13. |
| 19363967 | Background | Charakorn P, Cabanilla LL, Wagner WC, Foong WC, Shaheen J, Pregitzer R, Schneider D. The effect of preoperative ibuprofen on tooth sensitivity caused by in-office bleaching. Oper Dent. 2009 Mar-Apr;34(2):131-5. doi: 10.2341/08-33. |
| 26562735 | Background | Rezende M, Bonafe E, Vochikovski L, Farago PV, Loguercio AD, Reis A, Kossatz S. Pre- and postoperative dexamethasone does not reduce bleaching-induced tooth sensitivity: A randomized, triple-masked clinical trial. J Am Dent Assoc. 2016 Jan;147(1):41-9. doi: 10.1016/j.adaj.2015.07.003. Epub 2015 Nov 6. |
| 29696420 | Derived | da Costa Poubel LA, de Gouvea CVD, Calazans FS, Dip EC, Alves WV, Marins SS, Barcelos R, Barceleiro MO. Pre-operative use of dexamethasone does not reduce incidence or intensity of bleaching-induced tooth sensitivity. A triple-blind, parallel-design, randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):435-444. doi: 10.1007/s00784-018-2452-8. Epub 2018 Apr 25. |
| BG001 | Placebo | 35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . |
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| Primary | Visual Analogic Scale(0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | Posted | Mean | Standard Deviation | units on a scale | Twenty four hours |
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| Primary | Visual Analogic Scale(0-100) for Tooth Sensibility. | The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility | Posted | Mean | Standard Deviation | units on a scale | Forty eight hours |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | 35 patients in this group underwent the whitening procedure using the Potassium Nitrate intervention Potassium Nitrate: The volunteers in the Potassium Nitrate Group (Placebo group) received 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes . | 0 | 35 | 0 | 35 | 0 | 35 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |