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NCT Number: NCT05816525

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.

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Key information

Conditions

Deep Caries Pulp Hyperemia Pulpitis Reversible

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Western Uusimaa Wellbeing Services County

Espoo, Finland

Location status: Recruiting

Location contact

Eero Kerosuo, DDS, PhD, Docent

SUB_INVESTIGATOR

Katri Croft, DDS

CONTACT

Leo Tjäderhane, DDS, PhD, Professor

SUB_INVESTIGATOR

Sari Kervanto-Seppälä, DDS, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical and radiographic success at the follow up

    Time frame: 12-24 months

    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.

Secondary outcomes

  1. Symptoms 7 days post-treatment

    Time frame: 7 days

    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.

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

    Time frame: 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katri Croft, DDS

CONTACT

[email protected]

+358407367250

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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