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Retrospektiv evaluering av resultatene av direkte pulpakappbehandling

3. november 2026 oppdatert av: Funda Ozturk Bozkurt, Istanbul Medipol University Hospital

The aim of this retrospective study is to evaluate the vitality of teeth that had been treated with calcium hydroxide in direct pulp capping cases.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

During restorative procedures, pulp tissue may be exposed while caries is removed from deep dentin tissue. There are some defense mechanisms to protect against bacterial invasion, but the best barrier is provided by living pulp tissue. During the life of a tooth, living pulp tissue is responsible for the formation of secondary dentin, peritubular dentin, and repair dentin in response to biological or pathological stimuli. Direct pulp capping means closing the exposed pulp tissue with the aim of healing. Calcium hydroxide, a biocompatible material, has been used for many years in pulp capping, with its ability to reduce bacterial infection and promote dentinopulpal remineralization. However, the results regarding the long-term clinical success of direct pulp capping with calcium hydroxide are conflicting. After the calcium hydroxide application, the restoration should be done with a filling material that can prevent the bacteria transfer between the restoration and the tooth tissue in the long term. The success of the restoration has a significant impact on the healing and treatment outcome. The aim of this study is to evaluate the clinical success of 217 direct capping treatments and restorations ,which were routinely applied to 190 patients in our clinic between 2011 and 2020.

Individuals who were invited to the control session and approved to participate in the research with their signatures, to evaluate the result of direct capping treatment, will be examined by:

  • Visual examination: Related teeth and soft tissue will be examined.
  • Palpation: The apex of the related tooth will be palpated intra and extra orally.
  • Percussion: Percussion will be performed on the related tooth horizontally and vertically with a handpiece.
  • Cold test: Ethyl chloride (Chloraethyl, IGS AEROSOLS GMBH, Baden, Germany) cold spray is applied to a small cotton pellet to the symmetrical tooth, which is thought to be alive, for control purposes, and then to the cervical 1/3 of the relevant tooth for 2-3 seconds.Sensitivity will be asked. A sensitive tooth will be considered to have responded positively to the cold test. In the absence of sensitivity, the tooth will be considered to have given a negative response.
  • Electric pulp test: For control purposes, first the symmetrical tooth, which is thought to be alive, and then the related tooth will be tested with the Digitest Pulp Vitality Tester (Parkell, INC., New York, USA). Before the test, the teeth will be isolated from saliva with a cotton pad and toothpaste will be used as a conductive. During the application, the patient will be asked whether she/he has sensitivity. In case of sensitivity, the tooth will be deemed to have responded positively to the electrical pulp test and the relevant value will be recorded .If there is no sensitivity, the answer will be accepted as negative.
  • Radiographic examination: If swelling, fistula, inflammation or ulceration in the surrounding soft tissue is detected in the visual examination of the relevant tooth, radiological evaluation will be made with periapical radiography. If the patient has a panoramic radiograph obtained in the last 6 months for different treatment needs, it will be used during the clinical examination. Otherwise, a periapical radiograph will be taken from the patient.
  • The clinical performance of the restoration will be evaluated with the FDI criteria. Where necessary, digital camera restoration images will be taken.

Studietype

Observasjonsmessig

Registrering (Faktiske)

190

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Istanbul, Tyrkia (Türkiye), 34083
        • Istanbul Medipol University, Dental School

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The population of the study group consists of a dentist's patients that have been treated with calcium hydroxide as direct pulp capping between 2011-2020.

Beskrivelse

Inclusion Criteria:

  • Has to be one of the patients treated with calcium hydroxide as direct pulp capping

Exclusion Criteria:

  • Patients (treated with calcium hydroxide as direct pulp capping) who will not be available for the recall appointment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: RETROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with pulp capping treatment-related adverse events as assessed by vitality tests and intra-oral examination
Tidsramme: up to 11 years

Vitality tests (cold, electrical pulp test) and radiographical examination

up to 11 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of the restorations with FDI,World Dental Federation - clinical criteria for the evaluation of direct restorations.
Tidsramme: up to 11 years

The restorations will be evaluated for biological, esthetic and functional parameters as clinically acceptalbe and nonacceptable.

up to 11 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Funda Öztürk Bozkurt, fbozkurt@medipol.edu.tr

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mars 2024

Primær fullføring (Faktiske)

30. april 2025

Studiet fullført (Faktiske)

10. mai 2025

Datoer for studieregistrering

Først innsendt

11. mai 2022

Først innsendt som oppfylte QC-kriteriene

25. mai 2022

Først lagt ut (Faktiske)

31. mai 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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