- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05185206
Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Soumya S Shetty, MDS
- Telefonnummer: 8888200888
- E-mail: drsoumyasshetty@gmail.com
Studiesteder
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Maharashtra
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Pune, Maharashtra, Indien, 411018
- Rekruttering
- Dr D.Y. Patil Dental College and Hospital, Pimpri
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Kontakt:
- Soumya S Shetty, MDS
- Telefonnummer: 888820088
- E-mail: drsoumyasshetty@gmail.com
-
Kontakt:
- Riya A Parwani, BDS
- Telefonnummer: 9922929705
- E-mail: riyaparwani2307@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
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).
|
Eksperimentel: 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.
|
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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DYPDCH/IEC/123/99/19
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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