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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Procedure Subepithelial connective tissue
  Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants.
• Procedure Volume stable Collagen Matrix
  Study specific intervention is the placement of a soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants.
• Procedure No soft tissue augmentation
  Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed.

Primary outcome measures

• Absence of bleeding/ suppuration on probing [Time frame: 6 months after surgery]
• Increase in probing depth ≤ 1mm [Time frame: 6 months after surgery]
• Absence of additional bone loss after therapy of more than 5mm from radiographic baseline [Time frame: 6 months after surgery]

Secondary outcome measures (12)

• Profilometric changes around the treated implant [Time frame: 6 months after surgery]
• Profilometric changes around the treated implant [Time frame: 1 year after surgery]
• Profilometric changes around the treated implant [Time frame: 3 year after surgery]
• Profilometric changes around the treated implant [Time frame: 5 year after surgery]
• Early wound healing [Time frame: 1 month after surgery]
• Early wound healing [Time frame: 2 month after surgery]
• Radiographic evaluation of the amount of hard tissue [Time frame: 6 months after surgery]
• Radiographic evaluation of the amount of hard tissue [Time frame: 1 year after surgery]
• Radiographic evaluation of the amount of hard tissue [Time frame: 3 years after surgery]
• Radiographic evaluation of the amount of hard tissue [Time frame: 5 years after surgery]
• Oral Health Impact Profile-14 [Time frame: 6 months after surgery]
• Oral Health Impact Profile-14 [Time frame: 1 year after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carol — Frankfurt

Singapore · 1 center

• National Dental Centre Singapore — Singapore

Switzerland · 1 center

• Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich — Zurich

Identifiers

NCT: NCT05415111 · 2022 - 462

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗