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Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.

24. februar 2022 oppdatert av: Noha Magdy Salem Amen Eladly, Cairo University

Clinical and Radiographic Evaluation of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.

After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.

Studietype

Intervensjonell

Registrering (Faktiske)

8

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Giza, Egypt, 0020
        • Faculty of Dentistry -Cairo University

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

27 år til 45 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • • patients with healthy systemic condition.

    • Adult patients ˃ 18 years old.
    • hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
    • Alveolar socket Grade I and II.
    • Normal platelet counts according to complete blood count (CBC) test done in the screening stage.

Exclusion Criteria:

  • Acute infection at the extraction site

    • Smokers ˃ 10 cigarettes / day.
    • Medications that may interfere with wound healing
    • History of treatment with bisphosphonates.
    • History of allergic reaction

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: roll pedicle connective tissue graft with bovine bone
  1. sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted
  2. Atraumatic extraction was made by periotome.
  3. After tooth extraction the soft tissue was reflected at least 4 mm beyond the alveolar crest margin and the socket was filled with bovine derived xenograft and covered with roll pedicle connective tissue graft as a barrier membrane.
  4. This pedicle is rolled under the buccal mucosa.The palatal connective tissue pedicle graft was outlined by full thickness incision along the oblique incision line, and parallel incision given from the mesial line angle of target place and reflected coronally up to the crest of the ridge defect. then a partial thickness incision was made extending beyond the line angles of adjacent incisors and mucogingival junction, leaving the periosteum on the bone.
  5. the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap.
Fremgangsmåte: roll pedicle connective tissue graft with bovine bone
rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction
Andre navn:
  • vascularized interpositional connective tissue graft

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
width of alveolar bone
Tidsramme: changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months

Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.

The buccopalatal width of the alveolar ridge will be measured at the two assigned points using bone caliper at baseline and 6 months post extraction
changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
gingival thickness
Tidsramme: changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)

Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.

The gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted.

The gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 months post extraction.

months post extraction.
changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
height of the alveolar crest
Tidsramme: changes in height of alveolar crest were measured at baseline, 3 months and 6 months
Crestal bone height was measured to determine the amount of bone at gain using digora soft ware
changes in height of alveolar crest were measured at baseline, 3 months and 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Etterforskere

  • Hovedetterforsker: noha magdy salem amin, Cairo university- faculty of dentistry

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 (Faktiske)

16. juli 2019

Primær fullføring (Faktiske)

1. mars 2021

Studiet fullført (Faktiske)

16. september 2021

Datoer for studieregistrering

Først innsendt

8. februar 2022

Først innsendt som oppfylte QC-kriteriene

23. februar 2022

Først lagt ut (Faktiske)

24. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • roll pedicle graft

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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