LPRF Block vs. DBBM in Horizontal Bone Reconstruction
7. mai 2026 oppdatert av: Ana CASTRO SARDA, Universitaire Ziekenhuizen KU Leuven
Horizontal Guided Bone Regeneration: LPRF Block vs. a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up
split-mouth RCT. 12 patients.
horizontal GBR performed.
2 grafts were compared: test was LPRF block, control was 50% autogenous bone and 50% DBBM.
25 months follow-up.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
12 patients were included in this split-mouth RCT. In test sites a horizontal GBR procedure was performed using a collagen membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In control sites a collagen membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgia, 3000
- UZ Leuven
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Males or females, with ASA I or II, between 18 and 80 years old
- 2 implant sites requiring vertical bone augmentation prior to implant placement
- Both sites in the same jaw
- Good general health as documented by self-assessment
Exclusion Criteria:
- Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- Current pregnancy or breast feeding/ lactating at the time of recruitment.
- Radiotherapy or Chemotherapy in head and neck area.
- Intravenous and oral bisphosphonate therapy.
- Smoking
- Unwillingness to return for the follow-up examination.
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
- Presence of osseous pathologies, that might interfere with normal wound healing
- Presence of oral lesions (such as ulceration, malignancy)
- Local inflammation, including untreated periodontitis
- Patients with inadequate oral hygiene or unmotivated for adequate home care
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LPRF block group
LPRF block covered by collagen membrane
|
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
Andre navn:
|
|
Eksperimentell: Compound graft group
50% autogenous bone with 50% DBBM covered by collagen membrane.
|
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
bone volume changes
Tidsramme: at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
|
bone volume is measured on CBCT scans of the jaw
|
at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
buccal bone thickness on CBCT scan
Tidsramme: measured at placement of the implant and 1 year later
|
thickness of the buccal bone plate of the oral implant
|
measured at placement of the implant and 1 year later
|
|
Cumulative survival rate of the implants
Tidsramme: measured at the 1 year loading follow-up
|
survival of the implants over the follow-up time
|
measured at the 1 year loading follow-up
|
|
Rates of complications
Tidsramme: from the gbr surgery to 25 months follow-up
|
all possible complications were registered and monitored
|
from the gbr surgery to 25 months follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
2. juli 2018
Primær fullføring (Faktiske)
1. mars 2023
Studiet fullført (Faktiske)
1. mars 2023
Datoer for studieregistrering
Først innsendt
6. juni 2023
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- S59813-1
Plan for individuelle deltakerdata (IPD)
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NEI
IPD-planbeskrivelse
all info available on request
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