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A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants

9. februar 2017 oppdatert av: University of Michigan

Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft

This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

Studietype

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy adults of at least 18 years of age
  • Maxillary non-molar implant with failing pink esthetic profile
  • Implants with adjacent landmarks (only one can be an implant)
  • Healthy implants measured by the lack of peri-implantitis and mucositis
  • Good oral hygiene.

Exclusion Criteria:

  • Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
  • History of radiation or cancer in the oral cavity
  • Use of IV bisphosphonate or steroid medication
  • Use of tobacco products (>1/2 pack per day)
  • Pregnancy
  • Mucogingival surgery or implant placement within the past six months

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Connective Tissue Graft - Control
The donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars. A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin. A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique. The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension. Follow up was monitored over 6 months at various time-points.
Fremgangsmåte: Soft Tissue Grafting

All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared.

Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement.
Eksperimentell: Alloderm - Test
ADM graft was prepared according to the manufacturer's instructions. The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice. The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum. The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface. There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue. With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed. The graft was sutured with a single sling and the flap with a double sling. Simple interrupted sutures were used to close vertical releases.
Fremgangsmåte: Soft Tissue Grafting

All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared.

Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recession Correction
Tidsramme: 6 Months
Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
6 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concavity Correction
Tidsramme: 6 Months
At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.
6 Months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Tissue Thickness
Tidsramme: 6 Months
Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting.
6 Months
Implant Esthetics
Tidsramme: 6 Months
Implant esthetics were rated with written survey by both the subject and clinician.
6 Months
Psychosocial Data
Tidsramme: 6 months
Subjects completed questionnaires regarding their quality of life during the study by written survey.
6 months

Samarbeidspartnere og etterforskere

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

Sponsor

University of Michigan

Samarbeidspartnere

BioHorizons, Inc.

Etterforskere

  • Studiestol: Hom-Lay Wang, DDS, MS, PhD, University of Michigan

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. august 2009

Primær fullføring (Faktiske)

1. mai 2012

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

29. august 2013

Først innsendt som oppfylte QC-kriteriene

29. august 2013

Først lagt ut (Anslag)

4. september 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • UM-Anderson-10

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. .

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