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- Klinische proef NCT01934530
A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants
Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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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. |
Experimenteel: 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.
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Recession Correction
Tijdsspanne: 6 Months
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Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
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6 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Concavity Correction
Tijdsspanne: 6 Months
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At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.
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6 Months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Tissue Thickness
Tijdsspanne: 6 Months
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Tissue thickness was measured with a 25 endodontic file with rubber stopper at baseline, 6 weeks, 3 months and 6 months after grafting.
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6 Months
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Implant Esthetics
Tijdsspanne: 6 Months
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Implant esthetics were rated with written survey by both the subject and clinician.
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6 Months
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Psychosocial Data
Tijdsspanne: 6 months
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Subjects completed questionnaires regarding their quality of life during the study by written survey.
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6 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Hom-Lay Wang, DDS, MS, PhD, University of Michigan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- UM-Anderson-10
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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