Stepwise and One Step Techniques In Deep Dentin Lesion
Primary Purpose
Dental Caries, Dental Pulp Exposure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stepwise Excavation
One Step Excavation
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries, Dental Pulp Exposure focused on measuring Selective Caries Removal, Deep Dentin Lesion, Permanent Teeth, Stepwise and One Step Excavation Technique
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SW
OneS
Arm Description
stepwise excavation
one step excavation
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04351048
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
TIJEN PAMIR
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Pulp Exposure
Keywords
Selective Caries Removal, Deep Dentin Lesion, Permanent Teeth, Stepwise and One Step Excavation Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SW
Arm Type
Experimental
Arm Description
stepwise excavation
Arm Title
OneS
Arm Type
Experimental
Arm Description
one step excavation
Intervention Type
Procedure
Intervention Name(s)
Stepwise Excavation
Intervention Description
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
Intervention Name(s)
One Step Excavation
Intervention Description
*one step excavations is completed in the first stage via performing selective removal to soft dentine on pulpal wall of the cavities.
Primary Outcome Measure Information:
Title
Pulpal Success Assessment
Description
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
Time Frame
a 6-month periods
Title
Health Status of Periapical Tissue
Description
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
Time Frame
a 6-month periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tijen Pamir, Ph.D
Organizational Affiliation
Ege University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27099357
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.
Results Reference
background
PubMed Identifier
20572864
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.
Results Reference
background
PubMed Identifier
23207420
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.
Results Reference
background
PubMed Identifier
20971154
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.
Results Reference
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Stepwise and One Step Techniques In Deep Dentin Lesion
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