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

NCT05816525 | Recruiting

• 1 other identifier: PARTIALCARIESREMOVAL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Caries; Pulpitis Reversible; Pulp Hyperemia

Keywords

vital pulp therapy; deep carious lesion; selective carious tissue removal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptoms 7 days post-treatment

  7 days

• Pain severity using Visual Analogue Scale (VAS) 7 days post-treatment

  7 days

Interventions

Partial removal of carious tissue PROCEDURE

Nonselective carious tissue excavation will be performed in the periphery of the cavity to achieve a good marginal seal. In the pulpal wall selective, partial carious tissue excavation is performed to the soft dentin, removing tissue only the amount that is necessary for placing the restoration. The tooth is restored with high-viscosity glass-ionomer cement.

Final restoration PROCEDURE

The teeth will be restored with composite resin after 12 months follow up, if the tooth is asymptomatic, responds to sensibility tests and there are no periapical changes radiographically. Glass ionomer cement will be only partially removed to create space for the final restoration.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Western Uusimaa Wellbeing Services County

Espoo, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 28776717 BACKGROUND

Central Study Contacts

Katri Croft, DDS

CONTACT

+358407367250; katri.croft@helsinki.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, DDS, Specialist in Clinical Dentistry (Cariology and Endodontology), PhD candidate

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 18, 2023
• Study Start: April 21, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)