- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01896427
Comparing Pain and Swelling After Surgical Extraction of Mandibular Third Molar in Dexamethasone Injection and Without Corticosteroid Methods
6. juli 2013 oppdatert av: Mohammad Javad Shirani
In some cases, impacted wisdom teeth should be extracted.
Surgical extraction of these impacted third molars may provide special complication as pain, swelling, and trismus.
In previous studies, some techniques as sutureless flap closure, modified flap designing, antibiotic usage, and injection of corticosteroids were presented.
These methods are reducing post operative complications to moderate level.
In this study, pain, swelling, trismus, general patients' satisfaction, and associated quality of life after the surgical removal of third mandibular impacted molars will be compared while injection of dexamethasone (8mg) does not need excessive time, effort, and equipments and it will be injected in numbness area into medial pterygoid muscle and pterygomandibular space to current corticosteroid injecting non-corticosteroid methods.
To achieve this aim, 75 non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner, after provision of written informed consent will be entered to the study.
During the study, unwilling participants to continue the study and those with abnormality of wound healing process will be excluded.
The included participants will be assigned into three 25-people groups.
The surgeries were done by 3 same instructed experienced oral and maxillofacial residents.
After the surgery pain, swelling, trismus, general patients' satisfaction, and associated quality of life were evaluated using interview of questionnaire in 48 hour, 96 hour, and one week period of time.
The comparison was done between these three groups.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
75
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mohammadjavad Shirani, Dr
- Telefonnummer: 00989356039479
- E-post: javaad.sh_f@yahoo.com
Studiesteder
-
-
-
Isfahan, Iran, den islamske republikken, 81745-319
- Rekruttering
- Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
-
Ta kontakt med:
- Mohammadjavad Shirani, Dr
- Telefonnummer: 00989356039479
- E-post: javaad.sh_f@yahoo.com
-
Hovedetterforsker:
- Mohammadjavad Shirani, Dr
-
-
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 35 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Non pregnant participants have single impacted mandibular third molar in healthy and without pericoronitis manner
- They must have no contra-indication for injection of the corticosteroid and lidocaine with epinephrine
- Should not medicated by any possibly bias maker drug
- Type of the impaction, must not provide sever difficulty
- The participants should be mentally at healthy level and provide written informed consent to incorporate in the study
Exclusion Criteria:
-Unwilling participants to continue the study and those with abnormality of wound healing process
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Dexamethazone IO
For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space
|
single dose of dexamethasone (8mg) will injected
|
Aktiv komparator: Dexamethasone IM
For the case group, after the inferior alveolar block injection and before starting the surgery, single dose of dexamethasone (8mg) will injected into medial pterygoid and pterygomandibular space
|
single dose of dexamethasone (8mg) will injected
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in Pain
Tidsramme: 48 hours and one week after intervention
|
Visual analogue scale of pain- Number of required analgesics tablets
|
48 hours and one week after intervention
|
Changes in Swelling
Tidsramme: 48 hours and one week after intervention
|
Questionnaire and VAS
|
48 hours and one week after intervention
|
Changes in Trismus
Tidsramme: 48 hours and one week after intervention
|
Questionnaire
|
48 hours and one week after intervention
|
Changes in General patients' satisfaction
Tidsramme: 48 hours and one week after intervention
|
Visual analogue scale for satisfaction
|
48 hours and one week after intervention
|
Changes in Quality of life
Tidsramme: 96 hours and one week after intervention
|
Questionnaire
|
96 hours and one week after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Trismus
Tidsramme: one week period after the surgery
|
Questionnaire about Maximum mouth opening- Patients complaint
|
one week period after the surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Bijan Movahedian, Oral and maxillofacial surgeon, Department of oral and maxillofacial surgery, Faculty of Dentistry, Isfahan University of Medical Sciences
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
1. april 2013
Primær fullføring (Forventet)
1. april 2014
Datoer for studieregistrering
Først innsendt
30. juni 2013
Først innsendt som oppfylte QC-kriteriene
6. juli 2013
Først lagt ut (Anslag)
11. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. juli 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2013
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 292037 (Annet stipend/finansieringsnummer: Isfahan University of Medical Sciences)
- IRCT2013042713140N1 (Registeridentifikator: Iranian Registry of clinical trials)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .