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Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study

7. januar 2022 oppdatert av: Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital
Cention-N(commercially available restorative material) is a cost effective restoration for posterior restorations. Post-operative sensitivity is of great concern as far as any type of restorative material is concerned. Reduction of post-operative sensitivity is still a major on-going research. Timely advancement has lead to the discovery and usage of polymer bur for reduction of excess tooth removal, and thus reduction of sensitivity. Therefore the novelty of this study is comparision of the post operative sensitivity of Cention-N(commercially available restorative material) using conventional and polymer bur using Visual Analog Scale.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dental caries is a multifactorial disease which is very much prevalent in India occurring especially in high economic group and some in middle and lower economic groups of world population.The most common instruments used for excavation of dental caries are the use of diamond and carbide burs.There is effective removal of the carious tooth structure through these burs which leads to excess removal of tooth structure and weakening the teeth.

Timely advancement in dentistry and the quest for the development of ideal esthetic materials to replace lost dental tissue has led to use of Cention-N(commercially available restorative material) to restore posterior teeth. Cention N(commerically available restorative material) is a recently introduced tooth-coloured, basic filling material for bulk placement in retentive preparations with or without the application of an adhesive. It is an alkise restorative which is a new category of filling material, like compomer(commercially available restorative material) or ormocer(commercially available restorative material) and is essentially a subgroup of the composite resin. Cention-N(commercially available restorative material)offers a cost-effective substitute for amalgam and also fulfills the need of an esthetic bulk fill material in the posterior region. Patients have described post-operative sensitivity as a moderate pain, of short duration, that appears spontaneously when chewing, with hot and cold foods and on rare occasions with sweet and acid foods, and it disappears when the stimulus is removed. It is characterized by an acute pain that can last for days or weeks and disappears when the stimulus is removed.It results from the interaction between the restorative technique, the clinical condition of the tooth to be treated (health of the pulp and remaining hard dental tissue) and the restorative material. Therefore, there is a permanent and unpredictable possibility of sensitivity occurring. In addition, there are other factors related to the cause of post- operative sensitivity, such as the individual profile of each patient, the shape and extension of the cavity preparation and protection of the dentin-pulp complex. Hence the novelty of this study is to evaluate of the post operative sensitivity of Cention-n (commerically available restorative material)using conventional and polymer bur.

Studietype

Intervensjonell

Registrering (Forventet)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411018
        • Rekruttering
        • Dr D.Y. Patil Dental College and Hospital, Pimpri
        • Ta kontakt med:
        • Ta kontakt med:

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 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
  • Roots with closed apex.
  • Systematically healthy patients.
  • Patients with no other symptomatic tooth involved

Exclusion Criteria:

  • Teeth with the presence of any pathologic pulpal disease with or without pain.
  • Teeth with previous restorations, any defective restoration adjacent to or opposing the affected tooth.
  • Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
  • Patients with poor oral hygiene, severe, or chronic periodontitis.
  • Patient on medication which may hinder the response to sensitivity.

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Analysis of post-operative sensitivity after caries removal using conventional steel bur
Caries will be excavated using a carbide on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.
Enhet: Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with convention steel bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog Scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).
Eksperimentell: Analysis of post-operative sensitivity after caries removal using polymer bur
Caries will be excavated using a polymer on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.
Enhet: Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with polymer bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Tidsramme: Post operative sensitivity will be checked after 24 hours.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Post operative sensitivity will be checked after 24 hours.
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Tidsramme: Post operative sensitivity will be checked after 15 days.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Post operative sensitivity will be checked after 15 days.
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Tidsramme: Post operative sensitivity will be checked after 30 days.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.
Post operative sensitivity will be checked after 30 days.

Samarbeidspartnere og etterforskere

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

Sponsor

Dr. D. Y. Patil Dental College & Hospital

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)

2. mai 2020

Primær fullføring (Forventet)

30. desember 2021

Studiet fullført (Forventet)

30. juni 2022

Datoer for studieregistrering

Først innsendt

12. desember 2021

Først innsendt som oppfylte QC-kriteriene

7. januar 2022

Først lagt ut (Faktiske)

11. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. januar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DYPDCH/IEC/123/99/19

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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