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Controlling Post-extraction Complications of Impacted Mandibular Third Molar

20. juli 2021 opdateret af: Alaa Altaweel, Al-Azhar University

Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar

Impacted mandibular 3rd molar will be extracted in all patients, then patients will be divided, according to material placed in extraction socket into 3 groups: control, hyaluronic acid and honey. Then post extraction complications will be evaluated

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Impacted Mandibular third molar will be extracted under local anesthesia Through standard surgical flap elevation, after extraction and wound irrigation a material facilitate healing will be placed. According to material will be placed patients will be divide into 3 group: control ( no material, second group hyaluronic acid, third group ( honey).. then wound will be closed. Postoperative pain ( through visual analog scale) , edema, total dose of analgesic, mandibular movement (interincisal distance in mm) will be evaluated preoperative, 1,2,3,7, and 10 day after extraction

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • healthy patients
  • patient has impacted 3rd molar

Exclusion Criteria:

  • medically compromised patients Heavy smoking patients

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Normal saline
Normal saline irrigation after extraction and No drug placed in tooth socket
Medicin: Normal saline
Normal saline irrigation and No other drug placed after extraction
Aktiv komparator: Gengigel
Gengigel (Hyaluronic acid) placed after extraction
Medicin: Hyaluronic acid
Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
Andre navne:
  • Gengigel
Aktiv komparator: Methylprednisolone
Methylprednisolone will be given intravenous to a patient half an hour before the surgery
Medicin: Methylprednisolone
Methylprednsolone will be injected half an hour preoperatively
Aktiv komparator: Methylprednisolone and Gengigel
Methylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction
Medicin: Methylprednisolone and Hyaluronic acid
Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Interincisal distance
Tidsramme: Baseline (Preoperative)
Measuring distance between upper lower anterior teeth in mm
Baseline (Preoperative)
Interincisal distance
Tidsramme: 1 day postoperative
Measuring distance between upper lower anterior teeth in mm
1 day postoperative
Interincisal distance
Tidsramme: 2nd day postoperative
Measuring distance between upper lower anterior teeth in mm
2nd day postoperative
Interincisal distance
Tidsramme: 3rd day postoperative
Measuring distance between upper lower anterior teeth in mm
3rd day postoperative
Interincisal distance
Tidsramme: 7th day postoperative
Measuring distance between upper lower anterior teeth in mm
7th day postoperative
Assessment of pain using Visual analog scale
Tidsramme: Baseline (Preoperative)
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
Baseline (Preoperative)
Assessment of pain using Visual analog scale
Tidsramme: 1st day
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
1st day
Assessment of pain using Visual analog scale
Tidsramme: 2nd day
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
2nd day
Assessment of pain using Visual analog scale
Tidsramme: 3rd day
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
3rd day
Assessment of pain using Visual analog scale
Tidsramme: 7th day
Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain
7th day
Total amount of analgesic
Tidsramme: 1st day postoperative
Total amount of analgesic Will be calculated
1st day postoperative
Total amount of analgesic
Tidsramme: 2nd day postoperative
Total amount of analgesic Will be calculated
2nd day postoperative
Total amount of analgesic
Tidsramme: 3rd day postoperative
Total amount of analgesic Will be calculated
3rd day postoperative
Total amount of analgesic
Tidsramme: 7th day postoperative
Total amount of analgesic Will be calculated
7th day postoperative
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Tidsramme: Baseline
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
Baseline
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Tidsramme: 1st day postoperative
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
1st day postoperative
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Tidsramme: 2nd day postoperative
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
2nd day postoperative
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Tidsramme: 3rd day postoperative
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
3rd day postoperative
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle
Tidsramme: 7th day postoperative
Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively
7th day postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Al-Azhar University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. februar 2021

Primær færdiggørelse (Faktiske)

20. juni 2021

Studieafslutning (Faktiske)

20. juni 2021

Datoer for studieregistrering

Først indsendt

23. marts 2021

Først indsendt, der opfyldte QC-kriterier

24. marts 2021

Først opslået (Faktiske)

25. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Extraction healing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Preventing Postextraction Complication

Kliniske forsøg med Normal saline

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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