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NCT Number: NCT05415111

The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis

The key objective of the study is to compare the effects of soft tissue augmentation using a volume stable collagen matrix or autogenous connective tissue graft or no soft tissue augmentation in addition to bone grafting/implantoplasty in patients who undergo surgical therapy of peri-implantitis with respect to clinical resolution of the infection.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany

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About this study

The global burden of periimplantitis is expected to rise with the increasing popularity of dental implants as a replacement option. While many therapeutic interventions have been proposed, none have been proven superior. Surgical therapy is often indicated to gain access to the plaque infected implant threads and bone defects. Implantoplasty of suprabony defects have shown good results although adverse effects like soft tissue recession are common.

Thin mucosa results in compromised outcomes following various surgical interventions around implants with increased recession and aesthetic failures. It has also been associated with increased marginal bone loss and severity of periimplantitis. Application of autogenous connective tissue grafts during surgical therapy of periimplantitis to increase the keratinised mucosa widths or attenuate post-implantoplasty recession showed promising results.

No randomized controlled clinical trials investigating the effects of additional soft tissue augmentation with implantoplasty on periimplantitis lesions have been done so far. In addition, few have evaluated patient reported outcome measures, included non-European subjects and none reported on soft tissue alterations. The effect of soft tissue substitutes on surgical periimplantitis therapy remains unknown.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 years old (UZH, FRA) or > 21 years old (SIN), male and female.
  • Diagnosed with periimplantitis of at least 1 implant in function for at least 1 year Diagnostic criteria
  • Presence of bleeding and/or suppuration on gentle probing.
  • Probing depths of ≥6 mm.
  • Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.
  • Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium)
  • Good oral hygiene (full mouth plaque score <25%)
  • Adequate control of inflammation (full mouth BOP <25%)
  • Signed informed consent form

Exclusion criteria

  • Pregnant or lactating female patient at inclusion
  • Allergy or objection to porcine and bovine implantable biomaterials
  • Allergy to Penicillin or NSAIDs
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
  • Smoking > 15 cigarettes a day
  • Active periodontal disease

Treatment and study plan

Subepithelial connective tissue

Procedure

Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants.

Volume stable collagen matrix

Procedure

Study specific intervention is the placement of a soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants.

No soft tissue augmentation

Procedure

Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed.

Primary outcomes

  1. Absence of bleeding/ suppuration on probing

    Time frame: 6 months after surgery

    A parameter for monitoring periodontal conditions

  2. Increase in probing depth ≤ 1mm

    Time frame: 6 months after surgery

    A parameter for monitoring periodontal conditions

  3. Absence of additional bone loss after therapy of more than 5mm from radiographic baseline

    Time frame: 6 months after surgery

    A parameter for monitoring periodontal conditions

Secondary outcomes

  1. Profilometric changes around the treated implant

    Time frame: 6 months after surgery

    The profilometric changes will be evaluated based on intra-oral scans

  2. Profilometric changes around the treated implant

    Time frame: 1 year after surgery

    The profilometric changes will be evaluated based on intra-oral scans

  3. Profilometric changes around the treated implant

    Time frame: 3 year after surgery

    The profilometric changes will be evaluated based on intra-oral scans

  4. Profilometric changes around the treated implant

    Time frame: 5 year after surgery

    The profilometric changes will be evaluated based on intra-oral scans

  5. Early wound healing

    Time frame: 1 month after surgery

    The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5

  6. Early wound healing

    Time frame: 2 month after surgery

    The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5

  7. Radiographic evaluation of the amount of hard tissue

    Time frame: 6 months after surgery

    evaluation of the marginal bone level changes

  8. Radiographic evaluation of the amount of hard tissue

    Time frame: 1 year after surgery

    evaluation of the marginal bone level changes

  9. Radiographic evaluation of the amount of hard tissue

    Time frame: 3 years after surgery

    evaluation of the marginal bone level changes

  10. Radiographic evaluation of the amount of hard tissue

    Time frame: 5 years after surgery

    evaluation of the marginal bone level changes

  11. Oral Health Impact Profile-14

    Time frame: 6 months after surgery

    Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

  12. Oral Health Impact Profile-14

    Time frame: 1 year after surgery

    Patient's questionnaire - 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

  13. Oral Health Impact Profile-14

    Time frame: 3 years after surgery

    Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

  14. Oral Health Impact Profile-14

    Time frame: 5 years after surgery

    Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

Study contacts

Contact information is provided by the study sponsor or research team.

Jolanta Boruta

CONTACT

[email protected]

+41446343260

Silvia Rasi, Dr.

CONTACT

[email protected]

+4144643365

Sponsors and collaborators

Lead sponsor

Nadja Naenni

Other

Registry information

Official study title

The Adjunctive Effect of Soft Tissue Augmentation Procedures on the Surgical Treatment of Moderate-severe Peri-implantitis: A Randomized Controlled Clinical Trial.

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2022
Registry last updated
May 14, 2024

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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