Back to resultsThis is the Comparison of Clinical Effectiveness of Hydrochloric Acid-pumice Compound and Sodium Hypochlorite-pumice Compound Used in Microabrasion Technique for the Treatment of Dental Fluorosis. Change in Tooth Shade Was Checked Before and After the Procedure.
Primary Purpose
Dental Fluoroses
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
enamel microabrasion
Sponsored by
About this trial
This is an interventional treatment trial for Dental Fluoroses focused on measuring Hydrochloric Acid, Sodium Hypochlorite, Dental Fluorosis, Microabrasion Technique
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-40 years .
- Permanent dentition assessed on clinical examination.
- Have at least four maxillary incisors with scores of 4 to 5, according to the Dean's Fluorosis Index.
- Have no caries or restoration on the teeth to be treated assessed clinically.
Exclusion Criteria:
- Poor oral dental and general health assessed on clinical examination.
- History of Smoking and any form of tobacco.
- Patients with periodontal disease assessed on clinical examination.
- Caries on anterior teeth assessed on clinical examination.
- Hypersensitive teeth assessed on clinical examination.
Sites / Locations
- Fatima Jinnah Dental College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GROUP A (HYDROCHLORIC ACID)
GROUP B ( SODIUM HYPOCHLORITE)
Arm Description
Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide. The mixture (hydrochloric acid pumice compound) was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then change in shade was checked again with VITA classical A1-D4® shade guide.
Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide.The mixture (sodium hypochlorite pumice compound) was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then change in shade was checked again with VITA classical A1-D4® shade guide. .
Outcomes
Primary Outcome Measures
HYDROCHLORIC ACID PUMICE COMPOUND
Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline.
SODIUM HYPOCHLORITE PUMICE COMPOUND
Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT05339503
First Posted
March 20, 2022
Last Updated
April 26, 2022
Sponsor
Fatima Jinnah Dental College
1. Study Identification
Unique Protocol Identification Number
NCT05339503
Brief Title
This is the Comparison of Clinical Effectiveness of Hydrochloric Acid-pumice Compound and Sodium Hypochlorite-pumice Compound Used in Microabrasion Technique for the Treatment of Dental Fluorosis. Change in Tooth Shade Was Checked Before and After the Procedure.
Official Title
Comparison of Clinical Effectiveness of Hydrochloric Acid and Sodium Hypochlorite Used in Microabrasion Technique for the Treatment of Dental Fluorosis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Jinnah Dental College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the clinical effectiveness of hydrochloric acid-pumice compound and sodium hypochlorite-pumice compound in treating dental fluorosis using microabrasion technique.
Detailed Description
A Randomized Clinical Trial was taken Fatima Jinnah Dental College Hospital, Karachi, from 1st November 2019 To 30th April 2020. Total 30 teeth in each group were included. Preoperatively shade was checked. The mixture was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then changes in shade were checked. Descriptive statistics were calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Fluoroses
Keywords
Hydrochloric Acid, Sodium Hypochlorite, Dental Fluorosis, Microabrasion Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP A (HYDROCHLORIC ACID)
Arm Type
Experimental
Arm Description
Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide. The mixture (hydrochloric acid pumice compound) was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then change in shade was checked again with VITA classical A1-D4® shade guide.
Arm Title
GROUP B ( SODIUM HYPOCHLORITE)
Arm Type
Experimental
Arm Description
Total 30 teeth in each group were included. Preoperatively shade was checked with VITA classical A1-D4® shade guide.The mixture (sodium hypochlorite pumice compound) was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then change in shade was checked again with VITA classical A1-D4® shade guide.
.
Intervention Type
Other
Intervention Name(s)
enamel microabrasion
Intervention Description
It is a non-restorative, conservative treatment that works both chemically and mechanically to remove up to 0.2 mm of affected enamel per application. Pumice either mixed with 18% hydrochloric acid or 5.25% sodium hypochlorite was used to remove fluorosis stains.
Primary Outcome Measure Information:
Title
HYDROCHLORIC ACID PUMICE COMPOUND
Description
Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline.
Time Frame
30 minutes
Title
SODIUM HYPOCHLORITE PUMICE COMPOUND
Description
Tooth shade was recorded at the baseline with the help of VITA classical A1-D4® shade guide. The arrangement of the shades in the VITA classical family of shades is as follows: A1 - A4 (reddish-brownish), B1 - B4 (reddish-yellowish), C1 - C4 (greyish shades), D2 - D4 (reddish-grey).Determination of shade was done under daylight. Closest shade was selected from the shade tab. Effectiveness was marked positive if there was atleast one change in shade from the baseline just after the procedure to shade group from A1-D4. Effectiveness was marked negative if there is no change in shade from the baseline.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-40 years .
Permanent dentition assessed on clinical examination.
Have at least four maxillary incisors with scores of 4 to 5, according to the Dean's Fluorosis Index.
Have no caries or restoration on the teeth to be treated assessed clinically.
Exclusion Criteria:
Poor oral dental and general health assessed on clinical examination.
History of Smoking and any form of tobacco.
Patients with periodontal disease assessed on clinical examination.
Caries on anterior teeth assessed on clinical examination.
Hypersensitive teeth assessed on clinical examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAREEM A SATTAR, FCPS
Organizational Affiliation
Fatima Jinnah Dental College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima Jinnah Dental College
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75400
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
i will share the IPD once it will get published
Citations:
PubMed Identifier
32149058
Citation
Nevarez-Rascon M, Molina-Frechero N, Adame E, Almeida E, Soto-Barreras U, Gaona E, Nevarez-Rascon A. Effectiveness of a microabrasion technique using 16% HCL with manual application on fluorotic teeth: A series of studies. World J Clin Cases. 2020 Feb 26;8(4):743-756. doi: 10.12998/wjcc.v8.i4.743.
Results Reference
result
PubMed Identifier
24588784
Citation
Sheoran N, Garg S, Damle SG, Dhindsa A, Opal S, Gupta S. Esthetic management of developmental enamel opacities in young permanent maxillary incisors with two microabrasion techniques--a split mouth study. J Esthet Restor Dent. 2014 Sep-Oct;26(5):345-52. doi: 10.1111/jerd.12096. Epub 2014 Mar 4.
Results Reference
result
PubMed Identifier
28762354
Citation
Gupta A, Dhingra R, Chaudhuri P, Gupta A. A comparison of various minimally invasive techniques for the removal of dental fluorosis stains in children. J Indian Soc Pedod Prev Dent. 2017 Jul-Sep;35(3):260-268. doi: 10.4103/JISPPD.JISPPD_138_16.
Results Reference
result
Learn more about this trial
This is the Comparison of Clinical Effectiveness of Hydrochloric Acid-pumice Compound and Sodium Hypochlorite-pumice Compound Used in Microabrasion Technique for the Treatment of Dental Fluorosis. Change in Tooth Shade Was Checked Before and After the Procedure.
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