- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07709286
Clinical Efficacy of Antivet Versus Phosphoric Acid and Hydrochloric Acid in Microabrasion
Clinical Efficacy of Antivet Versus Phosphoric Acid and Hydrochloric Acid in Microabrasion Technique for Treatment of Stained Teeth: Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
- Oral prophylaxis will be provided by scaling and polishing of discolored teeth. Next, pre-operative color photographs of the teeth will be taken using a digital camera at a pre-established, standardized setting and focal length.
- tooth/teeth will be isolated with a Nic Tone dental dam and vaseline will be placed on gingival sulcus before placing dental dam.
- patient will be seated at a 45 degree angle.
- 5 drops of Antivet will be placed in the plastic mixing well that comes with the kit.Apply the ANTIVET solution over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter), the cotton pellet will be holded with the pliers that were provided in the kit and the pellet will be rubbed onto the surface in a sweeping motion from cervical to incisal.
- When the cotton pellet is pigmented by the tooth's staining, a new one will be used, the pellet will be saturated with the solution and the procedure will be repeated, this process will be repeated until the stain is removed. This process may take about 1 to 5 minutes per tooth. It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface.
- The tooth must not be dry at any given moment, otherwise the Antivet solution will not work properly.
- Before completing treatment, the last application will be applied with a new pellet and sweeping movements will be made from the distal surface towards the midline of the tooth.
- Once the tooth surface is free of stains, A dry cotton pellet or gauze will be used to remove any excess solution on the enamel.
- In a separate mixing well the NEUTRALIZING SOLUTION will be dispensed, the solution will be applied onto the tooth surface using a brush or microbrush and let it sit for 2 minutes. It is of utmost importance that the neutralizing solution will be applied completely up to the gingival margin.
- the dental dam will not removed until you the process has been completed with the neautralizing agent.
- The last step will be rinsing with water.
- postoperative photographs will be taken after one hour with the same condition as mentioned above.
Pre- and post-operative photographs of each patient will be shown to clinician other than operator who is unaware of the modality of treatment given to each group of patients. Then he will evaluate a score for improvement in appearance using a visual analog scale.
►B. Comparator Group 1
- Oral prophylaxis will be provided by scaling and polishing of discolored teeth. Next, pre-operative color photographs of the teeth will be taken using a digital camera at a pre-established, standardized setting and focal length.
- tooth/teeth will be isolated with a Nic Tone dental dam and vaseline will be placed on gingival sulcus before placing dental dam.
- patient will be seated at a 45 degree angle.
- Equal quantities from phosphoric acid 37% and aluminium oxid 50 micron will be mixed, thick mix will be applied on the affected tooth/teeth and will be rubbed with a rubber cup in a low-speed contra-angle handpiece for 60 seconds of each application. Every patient will be received the entire microabrasion treatment in a single appointment with a maximum of 6 applications. At the end of the treatment, MI Paste (GC America) will be applied for four minutes and then rubber dam will be removed.
- Patients will be instructed not to drink any colored drinks like tea, coffee and cola for 72 hours.
- postoperative photographs will be taken after one hour with the same condition as mentioned above.
- Pre- and post-operative photographs of each patient will be shown to clinician other than operator who is unaware of the modality of treatment given to each group of patients. Then he will evaluate a score for improvement in appearance using a visual analog scale.
C. Comparator Group 2
- Oral prophylaxis will be provided by scaling and polishing of discolored teeth. Next, pre-operative color photographs of the teeth will be taken using a digital camera at a pre-established, standardized setting and focal length.
- tooth/teeth will be isolated with a Nic Tone dental dam and vaseline will be placed on gingival sulcus before placing dental dam.
patient will be seated at a 45 degree angle.
- Microabrasion will be conducted using Opalustre (Ultradent Products Inc, South Jordan, UT, USA) will be applied onto the stained areas of the teeth. The microabrasion technique will be performed according to the manufacturer's instructions.
- A fine-grit diamond abrasive bur will be used initially for 5 to 10 seconds on the stained areas of the tooth to help the microabrasion slurry penetrate into the enamel. This will be followed by drying of the teeth and application of the microabrasion slurry of approximately 1- to 3-mm thickness onto the stained regions of the teeth using rubber prophy cups (OpalCups, Ultradent Products Inc) for 60 seconds.
- The teeth will be rinsed with water between slurry applications. Depending on the stain reduction, microabrasion will be repeated up to six times during the same appointment to achieve the desired result.
- At the end of the treatment, MI Paste (GC America) will be applied for four minutes and then rubber dam will be removed.
- Patients will be instructed not to drink any colored drinks like tea, coffee and cola for 72 hours.
- postoperative photographs will be taken after one hour with the same condition as mentioned above.
- Pre- and post-operative photographs of each patient will be shown to clinician other than operator who is unaware of the modality of treatment given to each group of patients. Then he will evaluate a score for improvement in appearance using a visual analog scale.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Esraa Esmeail Hussien EEH Lecturer, phd holder
- Telefonnummer: 0201111103836
- E-mail: dr.esraaism@gmail.com
Undersøgelse Kontakt Backup
- Navn: Dina Fayez Diab DFD Lecturer, phd holder
- Telefonnummer: +201146633390
- E-mail: Dina.Fayez.Diab@gmail.com
Studiesteder
-
-
Cairo Governorate
-
Badr, Cairo Governorate, Egypten, 11829
- Rekruttering
- Egyptian Russian University
-
Kontakt:
- Esraa Esmeail Hussien EEH lecturer, phd holder
- Telefonnummer: +201111103836
- E-mail: dr.esraaism@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Eligibility Criteria of participants:
Inclusion Criteria:
- Patients with moderate to mild stained teeth.
- 16-50 years.
- Males or Females.
- Co-operative patients approving to participate in the study.
Exclusion Criteria:
- High caries index with poor oral hygiene.
- Severe medical complications.
- Pregnancy.
- Xerostomia.
- Lack of compliance.
- Smokers
- Eligibility Criteria of teeth:
Inclusion Criteria of teeth:
- Anterior teeth.
- Mild to moderate intrinsic or extrinsic stains.
- Vital and non-sensitive anterior teeth.
Exclusion criteria of the teeth:
- pitted enamel.
- carious teeth.
- Deep lesions.
- Severe periodontal problems.
- Previous treatment for the stained teeth
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: phosphoric acid 37% and aluminium oxid 50 microns
Microabrasion technique could be considered as the first treatment option when trying to improve the esthetics of teeth that present with mild or moderate intrinsic stains as it is a simple, safe, atraumatic, minimally invasive single visit procedure with high success rate
|
● Equal quantities from phosphoric acid 37% and aluminium oxid 50 microns will be mixed, thick mix will be applied on the affected tooth/teeth and will be rubbed with a rubber cup in a low-speed contra-angle handpiece for 60 seconds of each application.
Every patient will be received the entire microabrasion treatment in a single appointment with a maximum of 6 applications.
|
|
Aktiv komparator: Opalustre™
a mixture of 37% phosphoric acid gel in extra fine grain pumice or 18% hydrochloric acid in pumice or 6.6% and 10% hydrochloric acid with silica carbide particles, with rubber cup in slow rotating motion to the areas of discoloration or white opacities.
Another advantage of microabrasion technique is that it leaves the treated enamel surface as highly polished which minimizes the cariogenic bacteria colonization and render it more resistant to demineralization
|
technique involves employing a mixture 6.6% hydrochloric acid with silica carbide particles, with rubber cup in slow rotating motion to the areas of discoloration or white opacities for 60 seconds. The teeth will be rinsed with water between slurry applications. Depending on the stain reduction, microabrasion will be repeated up to six times during the same appointment to achieve the desired result. . |
|
Eksperimentel: Antivet
The Antivet Kit solution is specially formulated to eliminate stains on the enamel surface caused by dental fluorosis or any other external factor.The tooth's surface is exposed to an acid solution by ionization by the fluoride absorbed in the apatite crystals (stains).
This reaction allows for the fluoride ions to separate from the fluoride ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel surface.
Once the stains are removed, a calcium hydroxide solution is applied to neutralize the residual acidic solution left on the tooth surface.
Lastly, the tooth is rinsed with water.Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic tricarboxylic acid, with a controlled pH of <3, necessary to react with the fluoride ions to form soluble salts.
The organic and inorganic ions are extracted from within the fluorapatite crystals through this ionization process which essentially allows the enamel surface to be
|
specially formulated to eliminate stains on the enamel surface caused by dental fluorosis or any other external factor.The tooth's surface is exposed to an acid solution by ionization by the fluoride absorbed in the apatite crystals (stains).
This reaction allows for the fluoride ions to separate from the fluoride ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel surface.
Once the stains are removed, a calcium hydroxide solution is applied to neutralize the residual acidic solution left on the tooth surface.
Lastly, the tooth is rinsed with water.Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic tricarboxylic acid, with a controlled pH of <3, necessary to react with the fluoride ions to form soluble salts.
The organic and inorganic ions are extracted from within the fluorapatite crystals through this ionization process which essentially allows the enamel surface to be cleansed without damaging it
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical performance
Tidsramme: three months
|
visual analog scale using scoring system
|
three months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Esraa Esmeail Hussien EEH Elhaddad, PHD, Misr university for science and technology
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 49
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tænder farvning
-
Ceren SireIkke rekrutterer endnu
-
Misr International UniversityNational Research Centre, EgyptAktiv, ikke rekrutterendePatienter med dybe karieslæsioner | Dyb karieslæsion | Deep Caries Lesion of Pemanent TeethEgypten