Clinical trial NCT04351048: Stepwise and One Step Techniques In Deep Dentin Lesion
Official title: The Evaluation of Stepwise and One Step Excavation Techniques In The Management of Deep Dentin Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries, Dental Pulp Exposure
Keywords: Selective Caries Removal
Deep Dentin Lesion
Permanent Teeth
Stepwise and One Step Excavation Technique
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pulpal Success Assessment
timeFrame: a 6-month periods
measure: Health Status of Periapical Tissue
timeFrame: a 6-month periods
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ege University
name: Tijen Pamir, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.