Dental CalculusNCT04216966
Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes
A study testing Gracey Curette, After Five and Mini Five in people with Dental Calculus, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The objective of the present study is to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette and Mini Five curette.Patients having chronic periodontitis and scheduled for extraction were randomized into four groups. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Calculus
- What is being tested?
- Gracey Curette, After Five and Mini Five
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Mar 2018to 7 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single Rooted Teeth diagnosed with severe chronic periodontitis
- Participants otherwise healthy
- Clinical Attachment Loss of >= 5mm
- Teeth with Millers Class 3 Mobility
- No alteration in root surface due to extraction procedure.
Who cannot join
- Teeth that had undergone root canal treatment
- Teeth associated with any periapical lesion
- History of scaling and root planing
- Any fractured teeth
- Any external resorption of root
- Any subgingival restoration or root caries
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the present study is to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette and Mini Five curette.Patients having chronic periodontitis and scheduled for extraction were randomized into four groups. Scaling and Root planing was performed by different curettes. Group 1 didn't under go any instrumentation. Group 2 was instrumented with Gracey curette, Group 3 with After Five curette and Group 4 with Mini Five curette. These hopeless teeth were then extracted atraumatically and the specimens were processed and analyzed under a Scanning Electron Microscope. "Roughness and Loss of Tooth substance index" and "Smear layer index" was evaluated using the Scanning Electron Microscope photographs.Means and frequencies were reported using SPSS Version-21.Cross Tabulation was made between the test groups (Control, Gracey Curette, After five and Mini Five) versus "Roughness and Loss of Tooth substance Index" and "Smear Layer Index". Chi square test was applied to see the grade distribution among groups. Frequencies were reported in percentages and means. P. value of 0.05 or less was considered as significant.
Read the detailed description
INTRODUCTION:
The main objective of scaling and root planing is to smoothen the root surface.Scaling and root planing can be done with a variety of instruments, however, hand instruments are still considered the "gold standard" for treatment. Hand and ultrasonic instruments are primarily used for debridement and produces root surface irregularities which enhances colonization of bacteria, deposition of plaque and retain more calculus.It is also a known fact that these debridement procedures produce a smear layer on the root surface which is detrimental to the healing and regeneration of periodontal tissues, as it interferes with the reattachment of cells derived from the periodontal ligament to the root surface.16
Objective:
The objective of the present study is to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette and Mini Five curette.
Study Design:
A Single Blinded Randomized Control Trial
Study Setting:
The study was conducted in the Periodontology Department of Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences Sample Size Using PASS software version 11, two independent sample t-test, 95% confidence interval, 80% power of test, roughness mean and standard deviation in group 1,hand instrument (1.2 ± 0.3um)54 and group 2,control (1.1 ± 0.56um)54 calculated sample size was 99 which was raised upto 120 teeth.
Sampling Technique:
Consecutive sampling
Clinical Procedure:
120 patients with ages between 35 - 60 years, having severe chronic periodontitis and scheduled for extraction were selected for this study. Detailed history was taken and a consent form was signed by the patient. Lingual surface of each tooth were subjected to debridement with any one of the test curettes. Patients were randomly assigned to any one of the four groups. Randomization was done by computer generated randomizing method. Randomization chart is given at the back.
Subgingival Instrumentation was performed in vivo by a single operator by either 5/6 Gracey Rigid Curette, 5/6 After Five Rigid Gracey curette or 5/6 Mini Five Rigid Gracey Curette. One group was not instrumented and kept as control. Local Anesthesia was given and scaling and root planing was performed until a smooth hard surface was detected by Explorer number 17. Following instrumentation, a small diamond round bur on a high speed hand piece was used to mark the level of the free gingival margin, lingually. This groove provided a landmark for evaluation under scanning electron microscope.
Instrumentation was carried out in vivo by a single operator trained in Periodontology, by a standard protocol. Modified pen grasp technique was used for holding the curettes. The angle between the cutting edge of the curette and the teeth was around 80 degree along with a good finger rest hence permitting a proper wrist-forearm motion. The shank of the instrument was kept parallel to the long axis of tooth. Degree of sharpness was maintained by sharpening the curettes after every 5 strokes with Arkansas stone.( Hu-Friedy Co, Chicago, IL, US) .The tooth were then extracted atraumatically as possible, with the beak of extraction forceps above the gingival margin. After extraction the teeth were rinsed in running tap water for 60 seconds to remove all the debris and blood and placed in 0.9% NaCl solution for hydration until treatment.After instrumentation the samples were fixed in 2.5 % gluteraldehyde solution in phosphate buffer (pH 7.3) for 24 hours and then washed with phosphate buffer 3 times. All specimens were kept for 10 minutes in graded series of ethanol (50%, 70%, 85%, 96% ethanol) for dehydration.139 They were dried overnight and then mounted on a 30 mm diameter aluminum stub with an adhesive tape. The specimens were sputter coated with a 300 Armstrong gold coating in the Auto coater .The scanning electron micrographs were taken from SEM .Each specimen was scored blindly by two investigators specialized in Oral Biology. Six SEM photographs with different standardized magnifications were taken for each specimen which were later assessed using the indices, "Roughness and Loss of Tooth Substance Index" and "Smear Layer Index".17, 57 "Roughness and Loss of Tooth substance index" was analyzed taking the magnifications (×100, ×200, and × 500) into consideration. "Smear layer index" was analyzed using the magnifications (×1000, × 2000, and × 5000) into consideration. For computation of Root Roughness and Smear layer Index a single value was represented by taking mode of the three readings taken on three different magnifications of both indices. The micrographs were assessed by two examiners blinded to the treatment groups. Inter-examiner reliability was checked to ensure the calibration of the examiners by applying Intra-class Correlation Coefficient (ICC) test.
Data was analyzed using SPSS Version 21.Descriptive statistics was computed regarding patients age, gender, brushing and flossing habits. Similarly descriptive statistics regarding teeth were made using frequencies and percentages. Graphs were made like pie chart using frequencies and bar charts using means. Cross Tabulation was made between the test groups (Control, Gracey Curette, After five and Mini Five) versus "Roughness and Loss of Tooth substance Index". Similarly Cross Tabulation was made between the test groups versus "Smear Layer Index". Chi square test was applied to see the grade distribution among groups. P. value of 0.05 or less was considered as significant.
- Conditions
- Dental Calculus
- Being tested
- Control group, Gracey Curette, After Five, Mini Five
- Medical subject headings
- Dental Calculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDevice
No intervention was given
Gracey CuretteDevice
Also called 5/6 Gracey Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Lingual surface of tooth was debrided by Gracey Rigid curette
After FiveDevice
Also called 5/6 After Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Lingual surface of tooth was debrided by After Five Rigid curette
Mini FiveDevice
Also called 5/6 Mini Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Lingual surface of tooth was debrided by Mini Five Rigid curette
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This group did not undergo any instrumentation. Receives: Device: Control group |
| Gracey Curette group | Experimental | Teeth under this group were subjected to debridement with Gracey curette . Receives: Device: Gracey Curette |
| After Five group | Experimental | Teeth under this group were subjected to debridement with After 5 curette . Receives: Device: After Five |
| Mini Five group | Experimental | Teeth under this group were subjected to debridement with Mini Five curette . Receives: Device: Mini Five |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Roughness
ROUGHNESS AND LOSS OF TOOTH SUBSTANCE INDEX
Measured: 1 week
Smear Layer
Smear Layer Index
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start7 Mar 2018
- Primary completion7 Oct 2018
- Study completion7 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental CalculusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Principal investigator, Sania Riaz, Dow University of Health Sciences
- Investigators
- Sania Riaz, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216966
- Sponsor's protocol ID
- 14071985
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slot DE, Koster TJ, Paraskevas S, Van der Weijden GA. The effect of the Vector scaler system on human teeth: a systematic review. Int J Dent Hyg. 2008 Aug;6(3):154-65. doi: 10.1111/j.1601-5037.2008.00319.x.
PubMed 18768018Mittal A, Nichani AS, Venugopal R, Rajani V. The effect of various ultrasonic and hand instruments on the root surfaces of human single rooted teeth: A Planimetric and Profilometric study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):710-7. doi: 10.4103/0972-124X.147405.
PubMed 25624626Schwarz F, Aoki A, Sculean A, Georg T, Scherbaum W, Becker J. In vivo effects of an Er:YAG laser, an ultrasonic system and scaling and root planing on the biocompatibility of periodontally diseased root surfaces in cultures of human PDL fibroblasts. Lasers Surg Med. 2003;33(2):140-7. doi: 10.1002/lsm.10201.
PubMed 12913887Yaghini J, Naghsh N, Attaei E, Birang R, Birang E. Root Surface Roughness After Scaling and Root Planing with Er:YAG Laser Compared to Hand and Ultrasonic Instruments by Profilometry. J Dent (Tehran). 2015 Dec;12(12):899-905.
PubMed 27559349Dahiya P, Kamal R, Gupta R, Pandit N. Comparative evaluation of hand and power-driven instruments on root surface characteristics: A scanning electron microscopy study. Contemp Clin Dent. 2011 Apr;2(2):79-83. doi: 10.4103/0976-237X.83065.
PubMed 21957380Aspriello SD, Piemontese M, Levrini L, Sauro S. Ultramorphology of the root surface subsequent to hand-ultrasonic simultaneous instrumentation during non-surgical periodontal treatments: an in vitro study. J Appl Oral Sci. 2011 Jan-Feb;19(1):74-81. doi: 10.1590/s1678-77572011000100015.
PubMed 21437474Riaz S, Ahmed S, Shabbir S, Khan ZR, Zaidi SJA, Naeem MM, Farooqui WA. Analysing root roughness and smear layer relationship by comparing contemporary dental curettes with conventional dental curettes: a randomised controlled trial. BMC Oral Health. 2022 Jun 17;22(1):237. doi: 10.1186/s12903-022-02268-1.
PubMed 35715802
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes
- ClinicalTrials.gov ID
- NCT04216966
- Acronym / sponsor ID
- 14071985
- Conditions
- Dental Calculus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Collaborators
- University of Karachi
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 7 Oct 2018 (actual)
- Study completion
- 7 Oct 2018 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present study is to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette and Mini Five curette.Patients having chronic periodontitis and scheduled for extraction were randomized into four groups. Scaling and Root planing was performed by different curettes. Group 1 didn't under go any instrumentation. Group 2 was instrumented with Gracey curette, Group 3 with After Five curette and Group 4 with Mini Five curette. These hopeless teeth were then extracted atraumatically and the specimens were processed and analyzed under a Scanning Electron Microscope. "Roughness and Loss of Tooth substance index" and "Smear layer index" was evaluated using the Scanning Electron Microscope photographs.Means and frequencies were reported using SPSS Version-21.Cross Tabulation was made between the test groups (Control, Gracey Curette, After five and Mini Five) versus "Roughness and Loss of Tooth substance Index" and "Smear Layer Index". Chi square test was applied to see the grade distribution among groups. Frequencies were reported in percentages and means. P. value of 0.05 or less was considered as significant.
Detailed description
INTRODUCTION:
The main objective of scaling and root planing is to smoothen the root surface.Scaling and root planing can be done with a variety of instruments, however, hand instruments are still considered the "gold standard" for treatment. Hand and ultrasonic instruments are primarily used for debridement and produces root surface irregularities which enhances colonization of bacteria, deposition of plaque and retain more calculus.It is also a known fact that these debridement procedures produce a smear layer on the root surface which is detrimental to the healing and regeneration of periodontal tissues, as it interferes with the reattachment of cells derived from the periodontal ligament to the root surface.16
Objective:
The objective of the present study is to evaluate the surface texture of root after hand instrumentation with Gracey curette, After Five curette and Mini Five curette.
Study Design:
A Single Blinded Randomized Control Trial
Study Setting:
The study was conducted in the Periodontology Department of Dr. Ishrat-ul-Ebad Khan Institute of Oral Health Sciences Sample Size Using PASS software version 11, two independent sample t-test, 95% confidence interval, 80% power of test, roughness mean and standard deviation in group 1,hand instrument (1.2 ± 0.3um)54 and group 2,control (1.1 ± 0.56um)54 calculated sample size was 99 which was raised upto 120 teeth.
Sampling Technique:
Consecutive sampling
Clinical Procedure:
120 patients with ages between 35 - 60 years, having severe chronic periodontitis and scheduled for extraction were selected for this study. Detailed history was taken and a consent form was signed by the patient. Lingual surface of each tooth were subjected to debridement with any one of the test curettes. Patients were randomly assigned to any one of the four groups. Randomization was done by computer generated randomizing method. Randomization chart is given at the back.
Subgingival Instrumentation was performed in vivo by a single operator by either 5/6 Gracey Rigid Curette, 5/6 After Five Rigid Gracey curette or 5/6 Mini Five Rigid Gracey Curette. One group was not instrumented and kept as control. Local Anesthesia was given and scaling and root planing was performed until a smooth hard surface was detected by Explorer number 17. Following instrumentation, a small diamond round bur on a high speed hand piece was used to mark the level of the free gingival margin, lingually. This groove provided a landmark for evaluation under scanning electron microscope.
Instrumentation was carried out in vivo by a single operator trained in Periodontology, by a standard protocol. Modified pen grasp technique was used for holding the curettes. The angle between the cutting edge of the curette and the teeth was around 80 degree along with a good finger rest hence permitting a proper wrist-forearm motion. The shank of the instrument was kept parallel to the long axis of tooth. Degree of sharpness was maintained by sharpening the curettes after every 5 strokes with Arkansas stone.( Hu-Friedy Co, Chicago, IL, US) .The tooth were then extracted atraumatically as possible, with the beak of extraction forceps above the gingival margin. After extraction the teeth were rinsed in running tap water for 60 seconds to remove all the debris and blood and placed in 0.9% NaCl solution for hydration until treatment.After instrumentation the samples were fixed in 2.5 % gluteraldehyde solution in phosphate buffer (pH 7.3) for 24 hours and then washed with phosphate buffer 3 times. All specimens were kept for 10 minutes in graded series of ethanol (50%, 70%, 85%, 96% ethanol) for dehydration.139 They were dried overnight and then mounted on a 30 mm diameter aluminum stub with an adhesive tape. The specimens were sputter coated with a 300 Armstrong gold coating in the Auto coater .The scanning electron micrographs were taken from SEM .Each specimen was scored blindly by two investigators specialized in Oral Biology. Six SEM photographs with different standardized magnifications were taken for each specimen which were later assessed using the indices, "Roughness and Loss of Tooth Substance Index" and "Smear Layer Index".17, 57 "Roughness and Loss of Tooth substance index" was analyzed taking the magnifications (×100, ×200, and × 500) into consideration. "Smear layer index" was analyzed using the magnifications (×1000, × 2000, and × 5000) into consideration. For computation of Root Roughness and Smear layer Index a single value was represented by taking mode of the three readings taken on three different magnifications of both indices. The micrographs were assessed by two examiners blinded to the treatment groups. Inter-examiner reliability was checked to ensure the calibration of the examiners by applying Intra-class Correlation Coefficient (ICC) test.
Data was analyzed using SPSS Version 21.Descriptive statistics was computed regarding patients age, gender, brushing and flossing habits. Similarly descriptive statistics regarding teeth were made using frequencies and percentages. Graphs were made like pie chart using frequencies and bar charts using means. Cross Tabulation was made between the test groups (Control, Gracey Curette, After five and Mini Five) versus "Roughness and Loss of Tooth substance Index". Similarly Cross Tabulation was made between the test groups versus "Smear Layer Index". Chi square test was applied to see the grade distribution among groups. P. value of 0.05 or less was considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Control groupThis group did not undergo any instrumentation. |
| Gracey Curette group | Experimental | Device: Gracey CuretteTeeth under this group were subjected to debridement with Gracey curette . |
| After Five group | Experimental | Device: After FiveTeeth under this group were subjected to debridement with After 5 curette . |
| Mini Five group | Experimental | Device: Mini FiveTeeth under this group were subjected to debridement with Mini Five curette . |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Single Rooted Teeth diagnosed with severe chronic periodontitis
- Participants otherwise healthy
- Clinical Attachment Loss of >= 5mm
- Teeth with Millers Class 3 Mobility
- No alteration in root surface due to extraction procedure.
Key exclusion criteria (6 listed)
- Teeth that had undergone root canal treatment
- Teeth associated with any periapical lesion
- History of scaling and root planing
- Any fractured teeth
- Any external resorption of root
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupNo intervention was given | Device | Control group |
| Gracey CuretteAlso: 5/6 Gracey Rigid curette (Hu-Friedy Co, Chicago, IL, US)Lingual surface of tooth was debrided by Gracey Rigid curette | Device | Gracey Curette group |
| After FiveAlso: 5/6 After Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)Lingual surface of tooth was debrided by After Five Rigid curette | Device | After Five group |
| Mini FiveAlso: 5/6 Mini Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)Lingual surface of tooth was debrided by Mini Five Rigid curette | Device | Mini Five group |
Primary outcome
Root Roughness
Time frame: 1 week
ROUGHNESS AND LOSS OF TOOTH SUBSTANCE INDEX
Smear Layer
Time frame: 1 week
Smear Layer Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 18768018Slot DE, Koster TJ, Paraskevas S, Van der Weijden GA. The effect of the Vector scaler system on human teeth: a systematic review. Int J Dent Hyg. 2008 Aug;6(3):154-65. doi: 10.1111/j.1601-5037.2008.00319.x.
- Background: PubMed 25624626Mittal A, Nichani AS, Venugopal R, Rajani V. The effect of various ultrasonic and hand instruments on the root surfaces of human single rooted teeth: A Planimetric and Profilometric study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):710-7. doi: 10.4103/0972-124X.147405.
- Background: PubMed 12913887Schwarz F, Aoki A, Sculean A, Georg T, Scherbaum W, Becker J. In vivo effects of an Er:YAG laser, an ultrasonic system and scaling and root planing on the biocompatibility of periodontally diseased root surfaces in cultures of human PDL fibroblasts. Lasers Surg Med. 2003;33(2):140-7. doi: 10.1002/lsm.10201.
- Background: PubMed 27559349Yaghini J, Naghsh N, Attaei E, Birang R, Birang E. Root Surface Roughness After Scaling and Root Planing with Er:YAG Laser Compared to Hand and Ultrasonic Instruments by Profilometry. J Dent (Tehran). 2015 Dec;12(12):899-905.
- Background: PubMed 21957380Dahiya P, Kamal R, Gupta R, Pandit N. Comparative evaluation of hand and power-driven instruments on root surface characteristics: A scanning electron microscopy study. Contemp Clin Dent. 2011 Apr;2(2):79-83. doi: 10.4103/0976-237X.83065.
- Background: PubMed 21437474Aspriello SD, Piemontese M, Levrini L, Sauro S. Ultramorphology of the root surface subsequent to hand-ultrasonic simultaneous instrumentation during non-surgical periodontal treatments: an in vitro study. J Appl Oral Sci. 2011 Jan-Feb;19(1):74-81. doi: 10.1590/s1678-77572011000100015.
- Derived from this study: PubMed 35715802Riaz S, Ahmed S, Shabbir S, Khan ZR, Zaidi SJA, Naeem MM, Farooqui WA. Analysing root roughness and smear layer relationship by comparing contemporary dental curettes with conventional dental curettes: a randomised controlled trial. BMC Oral Health. 2022 Jun 17;22(1):237. doi: 10.1186/s12903-022-02268-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sania Riaz principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gracey Curette, After Five and Mini Five in people with Dental Calculus, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Roughness (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216966, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.