- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
- 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.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Esraa Esmeail Hussien EEH Lecturer, phd holder
- 전화번호: 0201111103836
- 이메일: dr.esraaism@gmail.com
연구 연락처 백업
- 이름: Dina Fayez Diab DFD Lecturer, phd holder
- 전화번호: +201146633390
- 이메일: Dina.Fayez.Diab@gmail.com
연구 장소
-
-
Cairo Governorate
-
Badr, Cairo Governorate, 이집트, 11829
- 모병
- Egyptian Russian University
-
연락하다:
- Esraa Esmeail Hussien EEH lecturer, phd holder
- 전화번호: +201111103836
- 이메일: dr.esraaism@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
활성 비교기: 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. . |
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical performance
기간: three months
|
visual analog scale using scoring system
|
three months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Esraa Esmeail Hussien EEH Elhaddad, PHD, Misr university for science and technology
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 49
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .