- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608289
Socket Preservation Using Autogenous Dentin (SPAD)
20. maj 2026 opdateret af: University of Ostrava
Socket Preservation After Tooth Extraction Using Autogenous Dentin in Comparison With Other Techniques
Tooth extraction leads to a substantial reduction in alveolar bone volume, with up to 25% loss within the first year and up to 40-60% within three years.
This prospective randomized clinical study aims to compare four commonly used methods of alveolar ridge preservation, evaluating their effectiveness in maintaining bone volume for later prosthetic or implant rehabilitation.
Alveolar dimensions will be measured using calibrated CBCT imaging pre-extraction and at six months post-extraction.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
The study evaluates four different approaches to alveolar ridge preservation after tooth extraction.
Eligible patients aged 18-70 years will undergo minimally traumatic extraction.
Four treatment modalities will be compared: 1) Spontaneous healing secured with a stitch (control group), 2) Application of collagen sponge (Parasorb Cone, Resorba, Germany) secured with a stitch, 3) Application of a tricalcium phosphate xenograft (Poresorb TCP, Lasak, Czech Republic) covered with a collagen sponge (Parasorb Cone) and secured with a stitch.
4) Application of autogenous dentin, covered with a collagen sponge (Parasorb Cone) and secured with a stitch.
Alveolar ridge dimensions will be measured on CBCT before extraction and again after six months.
Primary outcomes include the absolute and relative change in ridge width and height at 1 mm, 3 mm, and 5 mm below the highest point of the alveolar bone as per Del Canto-Díaz, 2019.
Patient factors (periodontal biotype, soft tissue phenotype, and vestibular thickness of the alveolar bone) will be recorded to allow subgroup analysis.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Petr Jalůvka, MDDr.
- Telefonnummer: +420 596 623 518
- E-mail: petr.jaluvka@osu.cz
Studiesteder
-
-
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Ostrava, Tjekkiet, 70852
- Rekruttering
- University Hospital Ostrava
-
Kontakt:
- Martin Starosta, Assoc. Prof. MUDr., Ph.D.
- E-mail: martin.starosta@osu.cz
-
Ledende efterforsker:
- Petr Jalůvka, MDDr.
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 18-70 years
- no active periodontitis
- signed informed consent with participation in the study
- need for extraction of teeth other than third molars
- patients requesting only standard/reimbursed care
Exclusion Criteria:
- drug or alcohol abuse
- ongoing chemotherapy
- ongoing radiotherapy
- pregnancy
- ongoing treatment of osteoporosis or other biological treatment with MRONJ risk
- low compliance
- patients asking for premium care
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Spontaneous healing secured with a stitch (control group)
Wound after the tooth extraction will be secured with a stitch without addition of any augmentation material.
|
Wound after the tooth extraction will be secured with a stitch without addition of any augmentation material.
|
|
Eksperimentel: Colagen sponge
Wound after the tooth extraction will be filled with a collagen sponge (Parasorb Cone, Resorba, Germany) and secured with a stitch.
|
Wound after the tooth extraction will be filled with a collagen sponge (Parasorb Cone, Resorba, Germany) and secured with a stitch.
|
|
Eksperimentel: Tricalcium phosphate xenograft
Wound after the tooth extraction will be filled with tricalcium phosphate xenograft (Poresorb TCP, Lasak, Czech Republic), covered with a collagen sponge (Parasorb Cone, Resorba, Germany), and secured with a stitch.
|
Wound after the tooth extraction will be filled with tricalcium phosphate xenograft (Poresorb TCP, Lasak, Czech Republic), covered with a collagen sponge (Parasorb Cone, Resorba, Germany), and secured with a stitch.
|
|
Eksperimentel: Autogenous dentin
Wound after the tooth extraction will be filled with grounded autogenous dentin, covered with a collagen sponge (Parasorb Cone, Resorba, Germany), and secured with a stitch.
|
Wound after the tooth extraction will be filled with grounded autogenous dentin, covered with a collagen sponge (Parasorb Cone, Resorba, Germany), and secured with a stitch.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Alveolar bone width
Tidsramme: 6 months
|
Absolute and relative change in the alveolar bone width at 1 mm, 3 mm, and 5 mm below the alveolar crest measured from CBCT imagery.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Martin Starosta, Assoc. Prof., University of Ostrava
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
- Yuceer-Cetiner E, Ozkan N, Onger ME. Effect of Autogenous Dentin Graft on New Bone Formation. J Craniofac Surg. 2021 Jun 1;32(4):1354-1360. doi: 10.1097/SCS.0000000000007403.
- Lopez Sacristan H, Del Canto Pingarron M, Alobera Gracia MA, de Elio Oliveros J, Diaz Pedrero R, Seco-Calvo J. Use of autologous tooth-derived material as a graft in the post-extraction socket. Split-mouth study with radiological and histological analysis. BMC Oral Health. 2024 Jul 23;24(1):832. doi: 10.1186/s12903-024-04576-0.
- Isola G, Santonocito S, Di Tommasi S, Torrisi S, Iorio-Siciliano V, Caltabiano R, Ramaglia L, Torrisi P. Use of Autogenous Tooth-Derived Mineralized Dentin Matrix in the Alveolar Ridge Preservation Technique: Clinical and Histologic Evaluation. Int J Periodontics Restorative Dent. 2022 Jul-Aug;42(4):497-504. doi: 10.11607/prd.6170.
- Yang F, Ruan Y, Bai X, Li Q, Tang X, Chen J, Chen Y, Wang L. Alveolar ridge preservation in sockets with severe periodontal destruction using autogenous partially demineralized dentin matrix: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2023 Dec;25(6):1019-1032. doi: 10.1111/cid.13247. Epub 2023 Jul 16.
- Hussain AA, Al-Quisi AF, Abdulkareem AA. Efficacy of Autogenous Dentin Biomaterial on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial. Biomed Res Int. 2023 Dec 27;2023:7932432. doi: 10.1155/2023/7932432. eCollection 2023.
- Del Canto-Diaz A, de Elio-Oliveros J, Del Canto-Diaz M, Alobera-Gracia MA, Del Canto-Pingarron M, Martinez-Gonzalez JM. Use of autologous tooth-derived graft material in the post-extraction dental socket. Pilot study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e53-e60. doi: 10.4317/medoral.22536.
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 (Faktiske)
1. januar 2025
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPAD
Plan for individuelle deltagerdata (IPD)
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