Clinical trial NCT05415111: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Keywords: tissue augmentation of moderate-severe peri-implantitis
implantoplasty
collagen matrix
autogenous connective tissue graft
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) or soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants. Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed. The bone graft will remain permanently in the patients.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old (UZH, FRA) or \> 21 years old (SIN), male and female.
2. 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.
3. Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium)
4. Good oral hygiene (full mouth plaque score \<25%)
5. Adequate control of inflammation (full mouth BOP \<25%)
6. Signed informed consent form

Exclusion Criteria:

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

Primary outcomes:
measure: Absence of bleeding/ suppuration on probing
timeFrame: 6 months after surgery
measure: Increase in probing depth ≤ 1mm
timeFrame: 6 months after surgery
measure: Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Profilometric changes around the treated implant
timeFrame: 6 months after surgery
measure: Profilometric changes around the treated implant
timeFrame: 1 year after surgery
measure: Profilometric changes around the treated implant
timeFrame: 3 year after surgery
measure: Profilometric changes around the treated implant
timeFrame: 5 year after surgery
measure: Early wound healing
timeFrame: 1 month after surgery
measure: Early wound healing
timeFrame: 2 month after surgery
measure: Radiographic evaluation of the amount of hard tissue
timeFrame: 6 months after surgery
measure: Radiographic evaluation of the amount of hard tissue
timeFrame: 1 year after surgery
measure: Radiographic evaluation of the amount of hard tissue
timeFrame: 3 years after surgery
measure: Radiographic evaluation of the amount of hard tissue
timeFrame: 5 years after surgery
measure: Oral Health Impact Profile-14
timeFrame: 6 months after surgery
measure: Oral Health Impact Profile-14
timeFrame: 1 year after surgery
measure: Oral Health Impact Profile-14
timeFrame: 3 years after surgery
measure: Oral Health Impact Profile-14
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
city: Singapore
country: Singapore
facility: National Dental Centre Singapore
city: Zürich
country: Switzerland
facility: Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
Study officials:
affiliation: University of Zurich
name: Nadja Naenni, Dr.
role: PRINCIPAL_INVESTIGATOR
References: