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10 Year Follow-up on Reconstructive Bone Procedures for Peri-implantitis (periimpl10y)

30. juni 2026 oppdatert av: Viveca Wallin Bengtsson, Kristianstad University

10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study

The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes.

Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.

Studieoversikt

Detaljert beskrivelse

The objective of this 10-year observational follow-up study was to investigate the long-term clinical and radiographic outcomes of reconstructive surgical treatment and to evaluate potential differences between two reconstructive treatment protocols.

The study population consisted of patients previously treated for per-implantitis using one of the following approaches.

Group 1: Surgical treatment using a bone substitute material (Algipor) combined with a barrier membrane (Osseoquest)

Group 2: Surgical treatment using a bone substitute materail alone (Algipor)

At the time of treatment, all patients received systemic antibiotic therapy consisting of Amoxicillin 375 mg three times daily and Metronidazole 400 mg twice daily for 10 days, initiated one day before surgery.

The study aimed to provide further knowledge regarding the long-term effectiveness and stability of reconstructive peri-implantitis treatment and to investigate potential differences between the two treatment modalities.

Following surgery all patients participated in a structured supportive maintanance program with supportive periodontal therapy every third month and annual clinical evaluations.

At the 10 year follow-up examination, the implant(s) was assessed clinically and radiographically. Clinical parameters included probing pocket depht, bleeding on probing, suppuration, plaque accumulation and implant survival. Probing measurements were performed using a standardized probing force of 0.25 N with a calibrated periodontal probe.

Bleeding scores were recorded at four sites per implant using the following scale:

0=no bleeding

  1. bleeding point
  2. bleeding line
  3. drop of blood

Plaque accumulation was recorded as present or absent, following plaque disclosure.

To minimize examiner variability, all clinical examinations was performed by the same periodontist.

The primary outcome measures were radiographic bone fill and changes in probing pocket depth at treated implant sites. Secondary outcome measures included bleeding on probing, suppuration, plaque scores, and implant survival.

Statistical analyses were performed using parametric or non-parametric methods depending on data distribution. Statistical significance was defined as p< 0.05.

Patients received both oral and written information regarding the study and provided written informed consent prior to participation. Participation was voluntary and the participants could withdraw from the study at any time without consequences. The study had received approval from the appropiate ethical reiew authority.

Studietype

Observasjonsmessig

Registrering (Faktiske)

16

Kontakter og plasseringer

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

Studiesteder

    • Kristianstad
      • Kristianstad, Kristianstad, Sverige, 29198
        • Kristianstad 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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients diagnosed with at least one dental implant with peri-implantitis

Beskrivelse

Inclusion Criteria:

  • An implant demonstrating a progressive bone loss of ≥ 3 threads ( ≥ 1,8 mm) following the first year of healing
  • A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure
  • Bleeding on probing and/or suppuration should also be present

Exclusion Criteria:

-

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group 1
Bone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest)
Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane
Group 2
Bone reconstructive surgery with a bone graft material (Algipor)
Dental, implants with a diagnosis of peri.implantitis treated with reconstructive surgery and a bone graft alone

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone fill
Tidsramme: 10 years after surgical reconstrucyive bone procedures
Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph. Measurements will be performed by a blinded radiologist in mm and percent
10 years after surgical reconstrucyive bone procedures

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Probing pocket depths changes
Tidsramme: 10 years after surgical reconstructive bone procedures
Changes in probing pocket depths at the implant measured at four sites in mm
10 years after surgical reconstructive bone procedures

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bleeding
Tidsramme: 10 years after surgical reconstructive bone procedures
Bleeding on probing measured at the implant at four sites as present or absent
10 years after surgical reconstructive bone procedures
Graded bleeding
Tidsramme: 10 years after surgical reconstructive bone procedures
Graded bleeding measured at the implant at four sites as: 0=no bleeding 1= point of bleeding 2=line of bleeding and 3=drop of bleeding
10 years after surgical reconstructive bone procedures

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studieleder: Ann-Marie R Jansåker, Malmö University

Publikasjoner og nyttige lenker

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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)

1. mars 2000

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • P-I reconstructive surg 10 y

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

May be shared upon request

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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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