Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. juni 2026 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

16

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Ann-Marie R Jansåker, Malmö University

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.

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. marts 2000

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • P-I reconstructive surg 10 y

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

May be shared upon request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner