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Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes

Primary Purpose

Dental Calculus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control group
Gracey Curette
After Five
Mini Five
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Calculus

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Dr Sania Riaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control group

Gracey Curette group

After Five group

Mini Five group

Arm Description

This group did not undergo any instrumentation.

Teeth under this group were subjected to debridement with Gracey curette .

Teeth under this group were subjected to debridement with After 5 curette .

Teeth under this group were subjected to debridement with Mini Five curette .

Outcomes

Primary Outcome Measures

Root Roughness
ROUGHNESS AND LOSS OF TOOTH SUBSTANCE INDEX
Smear Layer
Smear Layer Index

Secondary Outcome Measures

Full Information

First Posted
December 18, 2019
Last Updated
January 3, 2020
Sponsor
Dow University of Health Sciences
Collaborators
University of Karachi
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1. Study Identification

Unique Protocol Identification Number
NCT04216966
Brief Title
Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes
Official Title
Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
October 7, 2018 (Actual)
Study Completion Date
October 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
Collaborators
University of Karachi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Calculus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
The scanning electron photographs were assessed by assessors who were blinded to the study groups.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group did not undergo any instrumentation.
Arm Title
Gracey Curette group
Arm Type
Experimental
Arm Description
Teeth under this group were subjected to debridement with Gracey curette .
Arm Title
After Five group
Arm Type
Experimental
Arm Description
Teeth under this group were subjected to debridement with After 5 curette .
Arm Title
Mini Five group
Arm Type
Experimental
Arm Description
Teeth under this group were subjected to debridement with Mini Five curette .
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
No intervention was given
Intervention Type
Device
Intervention Name(s)
Gracey Curette
Other Intervention Name(s)
5/6 Gracey Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Intervention Description
Lingual surface of tooth was debrided by Gracey Rigid curette
Intervention Type
Device
Intervention Name(s)
After Five
Other Intervention Name(s)
5/6 After Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Intervention Description
Lingual surface of tooth was debrided by After Five Rigid curette
Intervention Type
Device
Intervention Name(s)
Mini Five
Other Intervention Name(s)
5/6 Mini Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Intervention Description
Lingual surface of tooth was debrided by Mini Five Rigid curette
Primary Outcome Measure Information:
Title
Root Roughness
Description
ROUGHNESS AND LOSS OF TOOTH SUBSTANCE INDEX
Time Frame
1 week
Title
Smear Layer
Description
Smear Layer Index
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sania Riaz
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Sania Riaz
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18768018
Citation
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.
Results Reference
background
PubMed Identifier
25624626
Citation
Mittal 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.
Results Reference
background
PubMed Identifier
12913887
Citation
Schwarz 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.
Results Reference
background
PubMed Identifier
27559349
Citation
Yaghini 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.
Results Reference
background
PubMed Identifier
21957380
Citation
Dahiya 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.
Results Reference
background
PubMed Identifier
21437474
Citation
Aspriello 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.
Results Reference
background
PubMed Identifier
35715802
Citation
Riaz 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.
Results Reference
derived

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Evaluation of Root Roughness and Smear Layer Formation Using Conventional and Contemporary Dental Curettes

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