- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07906236
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth: A Randomized Clinical Trial
The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions.
A secondary purpose is to evaluate patient satisfaction and the psychosocial impact of the treatment on the esthetic perception of the treated children.
The results of all the research papers about treating enamel discoloration caused by hypomineralization with the ICON system can be accepted as satisfactory. However, not all cases achieved the full aesthetic aim.
Microabrasion is an acid abrasive removal and not the dissolution of enamel stain. It is as a treatment modality for enamel opacities like brown, orange, or yellow enamel spots; and fluorotic white streaks. Esthetic results could be reached when microabrasion followed by a remineralizing agent such as C PP-ACFP.
Null hypothesis, there is no difference between microabrasion followed by a remineralizing agent and resin infiltration treatment regarding clinical effectiveness & patient satisfaction.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Outcomes:
Primary outcome Color enhancement using Clinical photographs (Bhandari, et al., 2019). Secondary outcomes
- Patient satisfaction will be evaluated using Numerical scale (NS), (Figure 1). The participant marked the number that represented their self-assessed satisfaction (Rocha et al., 2020) as shown in Appenxix II.
- Psychosocial impact of the treatment on the esthetic perception of the treated children will be evaluated using The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) (Klages et al., 2006). Appendix III.
- Reducing teeth hypersensitivity will be evaluated using The Schiff Cold Air Sensitivity Scale (SCASS) (Schiff et al., 1994).
- Adverse and undesirable side effects experienced by the respondents: a) pain in teeth and gums will be evaluated using The Wong-Baker FACES® Pain Rating Scale (Wong et al., 1988). Appendix IV.
- b) bitter taste will be evaluated by asking the child right after treatment. (Athayde et al., 2022).
- Follow up:
Follow up after 1 day for adverse and undesirable side effects, 1week & 6 months.
Randomization:
The participants will be randomly assigned to one of the three experimental groups the interventions and control groups using simple randomization with a 1:1 allocation ratio.
Masking/blinding:
Neither the operator nor the patients could be blinded due to the nature of the study but the outcome assessor and statistician will be blinded.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Shaimaa AM Awad, Mcs
- Telefonnummer: 01027557531
- E-post: shaimaa.awad@dentistry.cu.edu.eg
Studera Kontakt Backup
- Namn: Aliaa AM Awad
- Telefonnummer: 01062811856
- E-post: shaimaa.awad@dentistry.cu.edu.eg
Studieorter
-
-
-
Cairo, Egypten
- Faculty of Dentistry, Cairo University
-
Kontakt:
- Shaimaa Awad, Mcs
- Telefonnummer: 01027557531
- E-post: shaimaa.awad@dentistry.cu.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
▪ Participants free from any systemic disease aged from 7 years to 12 years
- Anterior permanent teeth with Degree 1(mild) hypomineralization (according to the Wetzel and Reckel scale) (as shown in Appenxix I).
- Enamel opacities, (White, creamy or yellow to brownish colour), without enamel breakdown
- Caries-free teeth.
- Sensitivity to external stimuli e.g., air/water but not brushing.
Exclusion Criteria:
-
▪ Dental caries and filling,
- Loss of the enamel or dentin structure,
- Clinical symptoms of irreversible pulpitis such as spontaneous pain or persisting pain,
- Previous use of bleaching agent.
- Dental anomaly on anterior teeth,
- Periodontal diseases,
- Undergoing orthodontic treatment,
- Cognitive and behavioral conditions.
- Patients with milk protein or hydroxybenzoates allergies.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control group ICON® resin infiltration
Resin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children |
|
|
Experimentell: Intervention group 1
Opalustre® Enamel Microabrasion Slurry |
NOTE: For hypo-mineralization greater than 0.1-0.3mm use a fine-grit water-cooled tapered diamond bur, lightly sweep over the stained area for 5-10 seconds prior to applying Opalustre.
|
|
Experimentell: Intervention group 2
Antivet® enamel micro-abrasion |
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Color enhancement measured by Clinical photographs
Tidsram: 6 months
|
Clinical photographs will be taken with a digital camera macro lens, and flash. With the patient and digital camera at the same vertical plane and dental clinic illuminated evenly. The photographs will be taken in baseline, during the application time of the test or control. For standardizing the photographic conditions, the camera will be placed at the equidistance from the tooth. To prevent the change of refractive index by moisture, 30 s of drying of the lesion will be done. |
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient satisfaction measured by Visual analogue scale
Tidsram: 6 months
|
The patient is asked to draw a line perpendicular to the VAS at their perceived pain-intensity level, no discomfort (score 0), mild discomfort (score 1-3), moderate (score 4-6) and very severe (7-9) or worst discomfort (score 10). |
6 months
|
|
Reducing teeth hypersensitivity measured by The Schiff Cold Air Sensitivity Scale (SCASS)
Tidsram: 6 months
|
It is a behavioral scale because it is based on observed behavior in response to a stimulus beyond a certain threshold. The dentist (or another assessor present) rates the response of the patient to the stimulus as 0 for no response to air stimulus,
|
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shaimaa AM Awad, Mcs, Cairo Uviversity
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 261711198415920202321948291954
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