Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04351048
Other study ID # 70198063-050.06.0416-12.1/12
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 12, 2016
Est. completion date March 2023

Study information

Verified date August 2021
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date March 2023
Est. primary completion date March 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TIJEN PAMIR

References & Publications (4)

Bjørndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Näsman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennström 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. — View 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. Review. — View Citation

Innes NP, Frencken JE, Bjørndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Doméjean 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. — View Citation

Maltz M, Jardim JJ, Mestrinho HD, Yamaguti PM, Podestá 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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