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Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement

2. juni 2020 opdateret af: Dina Youssef Attia, Alexandria University

Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area

Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.

Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ten patients will be selected randomly from the outpatient clinic, Alexandria University seeking for an immediate implant placement. The sample will be selected to match the inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth extraction, placement of an immediate implant, bone grafting material and autologous soft tissue graft from the buccal pad of fat. Patients will be assessed clinically and radiographically to evaluate bone and soft tissue measurements.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

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 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients age between 20-45 years with no gender predilection.
  • Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
  • Patients with good oral hygiene.
  • Bony defects more than 2 mm during implant placement treated by bone substitute.
  • Patients fully capable to comply with the study protocol.

Exclusion Criteria:

  • Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
  • Heavy smokers (more than 20 cigarettes per day).
  • Sites with acute oral infection.
  • Pregnant and lactating patients.
  • Untreated periodontal disease.
  • Previous chemotherapy or irradiation of the head and neck.
  • Inadequate interocclusal space.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
10 patients will have immediate implant placement with buccal pad of fat free tissue
Procedure: Xenograft bone substitute (Osteo-biol)
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
Andre navne:
  • Implant(Superline®,DentiumCoTM)
  • Osstell(ISQ®)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Tidsramme: 6 months

Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using:

a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).
6 months
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Tidsramme: 6 months
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
6 months
Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Tidsramme: 6 months

Evaluation of soft tissue healing

At week 1, week4 and at 6 months:

Presence/absence of postoperative complications will be evaluated, including:

Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.
6 months
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
Tidsramme: 6 months
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
6 months
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
Tidsramme: 6 months

After 3 months then at 6 months Cone Beam CT will be requested in order to measure:

  • Bone density.
  • Amount of bone buccally and palatally to the implant.
  • Marginal bone loss.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Alexandria University

Efterforskere

  • Ledende efterforsker: Lobna Elwan, BSc, Alexandria University
  • Studieleder: Nagy El Prince, PhD, Alexandria University
  • Studieleder: Ahmed O. Swedan, PhD, Alexandria University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Forventet)

1. juli 2020

Primær færdiggørelse (Forventet)

13. oktober 2020

Studieafslutning (Forventet)

20. november 2020

Datoer for studieregistrering

Først indsendt

27. maj 2020

Først indsendt, der opfyldte QC-kriterier

2. juni 2020

Først opslået (Faktiske)

4. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Buccal pad of fat free tissue

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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