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Completed

NCT Number: NCT03977298

Surgical Protocol for Peri-Implantitis Treatment-4

Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%.

Based on the available data in literature, the surgical therapy for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.

Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Vita-Salute San Raffaele

Milan, Milano, 20100, Italy

About this study

Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis.

Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters. Numerous approaches have been used for implant surface decontamination during per-implant surgery, including mechanical, chemical and laser treatments. Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride. Another problem in maintaining implant health concerns the presence or absence of keratinised tissue around implant: if present, it seams to help the patient to maintain an optimal level of oral hygiene around implant and therefore the implant survival itself.

The aim of the present randomized controlled clinical trial is to assess the influence of keratinised tissue around implant in improving clinical parameters. In particular, implant surface will be decontaminated mechanically with titanium curettes and chemically using chlorhexidine; after this the bone defect will be filled with bio-materlal and a CTG around tissue implant will be randomized.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
  • PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
  • PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
  • single tooth and bridgework restorations without overhangs no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment)
  • treated chronic periodontitis and proper periodontal maintenance care FMPS < 20%
  • non-smoker or light smoking status in smokers (<10 cigarettes per day) implant function time ≥ 1 year.

Exclusion criteria

  • Patients with uncontrolled diabetes
  • patients with osteoporosis or under bisphosphonate medication,
  • pregnant or lactating women
  • patients with a history of radiotherapy to the head and neck region hollow implants
  • implant mobility
  • implants at which no position could be identified where proper probing measurements could be performed;
  • previous surgical treatment of the peri-implantitis lesions

Treatment and study plan

chlorhexidine

Procedure

Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine

CTG

Procedure

CTG will be positioned in the buccal aspect of the peri-implant tissue

Primary outcomes

  1. Bleeding on probing changes

    Time frame: baseline, 3, 6 and 12 months after treatment

    changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing

Secondary outcomes

  1. clinical attachment level changes

    Time frame: baseline, 3, 6 and 12 months after treatment

    changes in clinical attachment level, measured from CEJ to the tip of the probe

  2. probing pocket depth changes

    Time frame: baseline, 3, 6 and 12 months after treatment

    changes in probing depth probing, measured from gingival margin to te tip of the probe

  3. mucosal recession changes

    Time frame: baseline, 3, 6 and 12 months after treatment

    changes in mucosal recession, measured from CEJ to gingival margin

  4. bone level changes

    Time frame: baseline, 3, 6 and 12 months after treatment

    changes in bone level at mesial and distal aspect, measured on periapical X-ray

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Surgical Protocol for Peri-implantitis in Vertical Defect in Absence of Keratinised Tissue Using Chemical Decontamination With Chlorexidine and a CTG: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2019
Registry last updated
Sep 23, 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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