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Completed

NCT Number: NCT07678892

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kristianstad University

Kristianstad, 29198, Sweden

About this study

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

  • bleeding point
  • bleeding line
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Treatment with a bone graft and a membrane

Procedure

Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane

Treatment with a bone graft

Procedure

Dental, implants with a diagnosis of peri.implantitis treated with reconstructive surgery and a bone graft alone

Primary outcomes

  1. Bone fill

    Time frame: 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

Secondary outcomes

  1. Probing pocket depths changes

    Time frame: 10 years after surgical reconstructive bone procedures

    Changes in probing pocket depths at the implant measured at four sites in mm

Other outcomes

  1. Bleeding

    Time frame: 10 years after surgical reconstructive bone procedures

    Bleeding on probing measured at the implant at four sites as present or absent

  2. Graded bleeding

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kristianstad University

Other

Registry information

Official study title

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

Acronym: periimpl10y

Important dates

Study start
2000
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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