- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07704463
Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis
Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis (A Randomized Controlled Clinical Trial )
The goal of this clinical trial is to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.. The main question it aims to answer is:
whether the combined use of Laser pulpotomy with MTA capping material will provide faster healing with acceleration of complete root formation in immature permanent molars compared to MTA pulpotomy alone?
Participants will:
The coronal inflammed pulp will be carefully amputated to the level of the canal orifices.
Hemostasis will be achieved by gentle placement of a saline-moistened cotton pellet and Placement of capping material will be performed in the study groups.
The post-operative clinical follow up will be done after one week for patient reassurance. Then the postoperative clinical and radiographic follow-up will be scheduled up to twelve months.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Alexandria, Egypt
- Faculty of Dentistry
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Children with an age ranging between 6 to 14 years old with no gender predilection.
- Children free of any systemic disease or special health care needs.
- Patients complaining from intermittent or spontaneous, sharp, localized, diffuse, or referred pain.
- Selected teeth should give long lasting positive responses to cold testing.
- Soft tissues around the tooth are normal.
- Periapical radiographs show deep carious lesions.
- Patients with immature permanent molars (stages 8 and 9) according to Nolla's classification for tooth developmental stage.
- Periapical index score 1 or 2.
- Following pulpal amputation, hemostasis could be easily achievable within 5 to 10 minutes with a sterile moist cotton pellet.
Exclusion Criteria:
Child with bad experience of dental treatment (uncooperative patient).
- Non-restorable teeth.
- Negative response to cold testing.
- Bleeding could not be controlled.
- Absence of bleeding from any of the canals.
- Pus discharge through an associated sinus tract.
- Pulpal calcifications
- Radiographic signs of internal or external resorption.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Control group MTA pulpotomy
The remaining pulp will be capped with MTA.
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The remaining pulp will be capped with MTA after final rinsing with saline
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Eksperimentell: Test group 660 nm laser + MTA pulpotomy
Application of 660 nm diode laser and the remaining pulp will be capped with MTA.
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photobiomodulation (PBM) uses low-power irradiation from lasers or light-emitting diode (LED) devices to irradiate human tissues to stimulate dental pulp cells
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Eksperimentell: Test group 970 nm laser +MTA pulpotomy
Application of 970 nm diode laser and the remaining pulp will be capped with MTA.
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Laser application with 970 nm wavelength to penetrate and affect pulpal cells
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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1. Evaluation of laser effect on decreasing immediate postoperative pain using Numerical Rating Pain Scale with min (0) No pain - max (10) severe pain. 2. Evaluation of laser effect on dentin bridge formation (if it is radiographically present or not).
Tidsramme: 12 months
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12 months
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Aminosyrer, peptider og proteiner
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Undersøkelsesteknikker
- Epidemiologisk forskningsdesign
- Epidemiologiske metoder
- Forskningsdesign
- Metoder
- Utstyr og forsyninger
- Lasere
- Optiske enheter
- Strålingsutstyr og forsyninger
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Pemetrexed
- Kontrollgrupper
- Lasere, halvleder
Andre studie-ID-numre
- 0834-01/2024
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