Stepwise and One Step Techniques In Deep Dentin Lesion

NCT ID: NCT04351048

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-12
• Study Completion Date: 2023-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SW

stepwise excavation

Group Type: EXPERIMENTAL

Stepwise Excavation

Intervention Type: 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.

OneS

one step excavation

Group Type: EXPERIMENTAL

One Step Excavation

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TIJEN PAMIR

OTHER

Sponsor Role: lead

Responsible Party

TIJEN PAMIR

Prof Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tijen Pamir, Ph.D

Role: STUDY_DIRECTOR

Ege University

References

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.

Reference Type: BACKGROUND

PMID: 27099357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20572864 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23207420 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20971154 (View on PubMed)

Other Identifiers

70198063-050.06.0416-12.1/12

Identifier Type: -

Identifier Source: org_study_id