Stepwise and One Step Techniques In Deep Dentin Lesion

NCT04351048 | Unknown

• 1 other identifier: 70198063-050.06.0416-12.1/12
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries, Dental Pulp Exposure

Keywords

Selective Caries Removal; Deep Dentin Lesion; Permanent Teeth; Stepwise and One Step Excavation Technique

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

SW

EXPERIMENTAL

stepwise excavation

Procedure: Stepwise Excavation

OneS

EXPERIMENTAL

one step excavation

Procedure: One Step Excavation

Interventions

Stepwise Excavation PROCEDURE

* 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.

SW

One Step Excavation PROCEDURE

\*one step excavations is completed in the first stage via performing selective removal to soft dentine on pulpal wall of the cavities.

OneS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• TIJEN PAMIR: lead

Related Publications (4)

• 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.

  PMID: 27099357 BACKGROUND

• 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.

  PMID: 20572864 BACKGROUND

• 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.

  PMID: 23207420 BACKGROUND

• 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.

  PMID: 20971154 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Dental Pulp Exposure

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Pulp Diseases

Study Officials

• Tijen Pamir, Ph.D

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: December 12, 2016
• Primary Completion: March 2, 2018
• Study Completion: March 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-08