Dental Caries, Dental Pulp Exposure Clinical Trial
Official title:
The Evaluation of Stepwise and One Step Excavation Techniques In The Management of Deep Dentin Lesions
| Verified date | August 2021 |
| Source | Ege University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| TIJEN PAMIR |
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
| 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 |