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Effektiviteten av et kitosandressing i pulpotomi av umodne permanente tenner

20. september 2026 oppdatert av: Salsabil Mohammed Naguib, Minia University

Effekten av et kitosandressing ved pulpotomi av umodne permanente tenner: Randomisert klinisk studie

Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.

Clinically, the characteristic and the extent of pulpal hemorrhage at the exposure site are the most important outcome predictors for assessing pulpal status.

reported that excessive bleeding from the pulp revealed a significantly lower incidence of success compared with moderate bleeding. A variety of solutions and methods have been used to obtain pulpal hemostasis. Despite its limited effect on pulpal healing, sterile saline is a frequently used agent. Sodium hypochlorite (NaOCl), in concentrations of 0.5percent, achieves hemostasis without affecting pulpal repair mechanism and healing.

Hemostatic dressings have emerged as valuable adjuncts in dentistry, offering effective and efficient control of bleeding during various dental procedures. The different types of hemostatic dressings, including oxidized cellulose, gelatin- based, chitosan, and calcium-based dressings, provide localized hemostasis, reduce chair time, and improve patient outcomes.

Recently, the concept of lesion sterilization and tissue repair therapy involve the use of a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected.

Chitosan is a natural and non-toxic polysaccharide with unique biological properties such as antimicrobial, anti- fungal, anti-inflammatory, antiseptic, antitumor, hemostatic,

immune adjuvant, regenerative effect and wound healing. In dentistry, it can be used as a dental pulp capping material, mouth rinse, chewing gum, drug device for root canal disinfection, topical treatment of periodontitis and blood hemostasis after tooth extraction.

Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible.

Studietype

Intervensjonell

Registrering (Faktiske)

26

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

      • Minya, Egypt
        • Minia University Hospital

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

7 år til 15 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with immature maxillary anterior teeth.
  • Patients with caries or traumatic exposed teeth .
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
  • Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

  • Patients with mature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with signs of periapical inflammation.
  • Patients who could/would not participate in a 1-year follow-up.
  • Teeth with periodontal involvement.
  • Teeth with vertical root fractures.
  • Non- restorable teeth.
  • cases with previously initiated endodontic treatment.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group Hemcon Dressing

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth.

To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth

Andre navn:
  • Hemcon-dressing
  • pulpotomi av umodne permanente tenner
  • Bomull fuktet med isotonisk saltvann
Aktiv komparator: Group of Cotton damped with normal saline

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth.

To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth

Andre navn:
  • Hemcon-dressing
  • pulpotomi av umodne permanente tenner
  • Bomull fuktet med isotonisk saltvann

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post Operative Pain
Tidsramme: 72 Hours

Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

72 Hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of root completion
Tidsramme: at 6 and 12 months

Assessment of root completion using standardized periapical radiograph at 6 and 12 months\periods.

at 6 and 12 months

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studiestol: Lamiaa Ahmed Ebrahem, Professor, Department of endodontics Dean of Faculty of Dentistry Fayoum University

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)

25. august 2025

Primær fullføring (Faktiske)

20. august 2026

Studiet fullført (Faktiske)

25. august 2026

Datoer for studieregistrering

Først innsendt

27. november 2025

Først innsendt som oppfylte QC-kriteriene

31. desember 2025

Først lagt ut (Faktiske)

7. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2026

Sist bekreftet

1. august 2025

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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