NCT04216966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 18, 2019

Last Update Submit

January 3, 2020

Conditions

Dental Calculus

Outcome Measures

Primary Outcomes (2)

  • Root Roughness

    ROUGHNESS AND LOSS OF TOOTH SUBSTANCE INDEX

    1 week

  • Smear Layer

    Smear Layer Index

    1 week

Study Arms (4)

Control group

PLACEBO COMPARATOR

This group did not undergo any instrumentation.

Device: Control group

Gracey Curette group

EXPERIMENTAL

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

Device: Gracey Curette

After Five group

EXPERIMENTAL

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

Device: After Five

Mini Five group

EXPERIMENTAL

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

Device: Mini Five

Interventions

Control groupDEVICE

No intervention was given

Control group
Gracey CuretteDEVICE

Lingual surface of tooth was debrided by Gracey Rigid curette

Also known as: 5/6 Gracey Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Gracey Curette group
After FiveDEVICE

Lingual surface of tooth was debrided by After Five Rigid curette

Also known as: 5/6 After Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
After Five group
Mini FiveDEVICE

Lingual surface of tooth was debrided by Mini Five Rigid curette

Also known as: 5/6 Mini Five Rigid curette (Hu-Friedy Co, Chicago, IL, US)
Mini Five group

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Sania Riaz

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 18768018BACKGROUND

  • 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.

    PMID: 25624626BACKGROUND

  • 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.

    PMID: 12913887BACKGROUND

  • 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.

    PMID: 27559349BACKGROUND

  • 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.

    PMID: 21957380BACKGROUND

  • 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.

    PMID: 21437474BACKGROUND

  • 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.

    PMID: 35715802DERIVED

MeSH Terms

Conditions

Dental Calculus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sania Riaz

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The scanning electron photographs were assessed by assessors who were blinded to the study groups.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduate trainee

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 3, 2020

Study Start

March 7, 2018

Primary Completion

October 7, 2018

Study Completion

October 7, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)