The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue

The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are:

• Do preoperative symptoms affect the outcome?
• Does the depth of the carious lesion affect the outcome?

One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months.

The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.

Study Overview

• Status: Recruiting
• Conditions: Deep Caries; Pulpitis Reversible; Pulp Hyperemia
• Intervention / Treatment: Procedure: Partial removal of carious tissue; Procedure: Final restoration

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Katri Croft, DDS; Phone Number: +358407367250; Email: katri.croft@helsinki.fi

Study Locations

• Finland
  • Espoo, Finland
    • Recruiting
    • Western Uusimaa Wellbeing Services County
    • Contact: Katri Croft, DDS
    • Sub-Investigator: Sari Kervanto-Seppälä, DDS, PhD
    • Sub-Investigator: Leo Tjäderhane, DDS, PhD, Professor
    • Sub-Investigator: Eero Kerosuo, DDS, PhD, Docent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The first 100 consecutive patients that have entered the dental clinics involved, fulfilling the inclusion criteria, have given their informed consent, and have responded to the questionnaire after 7 days post-treatment, will be recruited.

Description

Inclusion Criteria:

• the patient is communicating in the Finnish or English language
• a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph
• asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)
• pulp responding to the electric pulp testing and cold testing
• the periodontal stage of the tooth should be I or II.

In case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study.

Exclusion Criteria:

• general medical condition which makes the patient more susceptible to odontogenic infection complications
• pregnancy, breastfeeding
• mental retardation, memory disorder
• the carious lesion is extending to more than three surfaces or to both proximal surfaces
• the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries
• the tooth is not restorable
• periapical changes in the periapical radiograph
• sensitivity to percussion; swelling; sinus tract; increased mobility; resorption
• furcal lesion more severe than Class I
• ongoing orthodontic treatment
• declining to sign the written consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographic success at the follow up	Symptoms and the clinical condition of the tooth will be evaluated at the follow up. In particular, the response of the tooth to both cold and EPT will be tested. In addition, a periapical radiograph will be taken. An asymptomatic tooth that responds positively to sensibility testing (both cold and EPT) and has no signs of infection clinically or in a periapical radiograph, is considered a success.	12-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms 7 days post-treatment	The participants will be asked to fill in an electronic questionnaire 7 days after the partial carious tissue removal. The participants will be asked whether the tooth was asymptomatic or symptomatic i) pre-treatment and ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment. Multi-choice questions will be used to find out about the nature and intensity of pain.	7 days
Pain severity using Visual Analogue Scale (VAS) 7 days post-treatment	The participants will be asked to fill in an electronic Visual Analogue Scale (VAS) 7 days after the partial carious tissue removal. VAS will be used to assess the severity of pain experienced. The scale will be 0-10, 0 indicating no pain and 10 indicating worst pain imaginable. The participants will be asked about pain severity i) pre-treatment, ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment.	7 days

Collaborators and Investigators

• Sponsor: University of Helsinki

Publications and helpful links

General Publications

• Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: vital pulp therapy; deep carious lesion; selective carious tissue removal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Hyperemia
• Other Study ID Numbers: PARTIALCARIESREMOVAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No