Stepwise and One Step Techniques In Deep Dentin Lesion

Sponsor

TIJEN PAMIR (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04351048

Collaborator

(none)

Enrollment

Arms

74.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries, Dental Pulp Exposure	Procedure: Stepwise Excavation Procedure: One Step Excavation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 12, 2016

Actual Primary Completion Date :

Mar 2, 2018

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pulpal Success Assessment [a 6-month periods]
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
Health Status of Periapical Tissue [a 6-month periods]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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