Stepwise and One Step Techniques In Deep Dentin Lesion

The Evaluation of Stepwise and One Step Excavation Techniques In The Management of Deep Dentin Lesions

This double blind, randomized, controlled clinical trial aimed to observe the success of stepwise (SW) and one step (OneS) excavation techniques in the management of deep dentin caries. Additionally, evaluation of glass ionomer cement (GIC) as temporary restorative was also performed. For this purpose, forty participants were selected among the routine patients coming to university clinic. A permanent tooth having caries lesions penetrating to 75 percentage or more of dentin of patient were included. Randomization to SW and OneS groups were organized by coin method. The periphery of the cavities including enamel-dentin junction was cleaned until reach to hard dentin. Afterwards, selective removal to soft dentin on the pulpal side of the cavities was applied manually excavation and covered with pure calcium hydroxide and zinc oxide eugenol cement. GIC was used for temporary filling. This process was implemented both the first stage excavation of SW and OneS groups. Clinical and radiographic evaluations were performed at 6 months according to clinical signs and symptoms and radiographic sings using Periapical Index (PAI). Besides, temporary restorations were evaluated according to the of Ryge/Modified USPHS criteria. Following this evaluation, on the SW group, the cavities was re-entered and selective removal was applied up to firm dentin and pulp-capping were applied as mentioned above. In OneS group, temporary restoration was reduced as a base. All of the cavities were permanently restored with resin composite. Whole procedure was completed at one centre by a specialist, and control sessions was performed two experienced experts. Participants and experts were blinded in this study.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries, Dental Pulp Exposure
• Intervention / Treatment: Procedure: Stepwise Excavation; Procedure: One Step Excavation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Molar teeth with primary caries lesion prolonged of 75 percentage or more of dentin radiographically1 Existence of vitality with positive response to

  • electrical pulp test and
  • cold test
• No history of spontaneous pain on the teeth
• No sign of pain on percussion and palpation (sensitivity)

Exclusion Criteria:

• Individuals with the systemic disease who require hospitalization (oncological treatment, transplantation patients)
• Patients with uncontrolled hyperglycaemia or using insulin
• Patients with pregnancy/suspected
• Observation of radiolucency in the apex of the relevant tooth (PAI> 2)
• Secondary decayed teeth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SW; stepwise excavation	Procedure: Stepwise Excavation; stepwise excavation includes selective caries removal to soft dentine on pulpal wall in the first stage of the excavation and; after six months, the second stage of intervention includes re-entring the cavities and wall selective removal to firm dentine on pulpal wall.
Experimental: OneS; one step excavation	Procedure: One Step Excavation; *one step excavations is completed in the first stage via performing selective removal to soft dentine on pulpal wall of the cavities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulpal Success Assessment	Presence of vitality in treated tooth with positive response to electrical and thermal stimuli, no history of spontaneous pain and no response to percussion and pain (sensitivity) sign in palpation	a 6-month periods
Health Status of Periapical Tissue	According to Orstavik' Periapical Index (PAI), Periapical Index score scale are 1to 5 : scoring with PAI 1 or PAI 2 refer to healthy tooth but PAI 3, PAI 4 and PAI 5 as worse outcome for periapical tissue that sing of periapical tissue damage	a 6-month periods

Collaborators and Investigators

• Sponsor: TIJEN PAMIR
• Investigators: Study Director: Tijen Pamir, Ph.D, Ege University

Publications and helpful links

General Publications

• Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.
• Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
• Maltz M, Jardim JJ, Mestrinho HD, Yamaguti PM, Podesta K, Moura MS, de Paula LM. Partial removal of carious dentine: a multicenter randomized controlled trial and 18-month follow-up results. Caries Res. 2013;47(2):103-9. doi: 10.1159/000344013. Epub 2012 Nov 28.
• Hayashi M, Fujitani M, Yamaki C, Momoi Y. Ways of enhancing pulp preservation by stepwise excavation--a systematic review. J Dent. 2011 Feb;39(2):95-107. doi: 10.1016/j.jdent.2010.10.012. Epub 2010 Dec 3.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): March 2, 2018
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Permanent Teeth; Selective Caries Removal; Deep Dentin Lesion; Stepwise and One Step Excavation Technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Pulp Diseases; Dental Caries; Dental Pulp Exposure
• Other Study ID Numbers: 70198063-050.06.0416-12.1/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No