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

NCT05415111 | Recruiting

• 1 other identifier: 2022 - 462
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 3

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.

Conditions

Peri-Implantitis

Keywords

tissue augmentation of moderate-severe peri-implantitis; implantoplasty; collagen matrix; autogenous connective tissue graft

Outcome Measures

Primary Outcomes (3)

• Absence of bleeding/ suppuration on probing

  A parameter for monitoring periodontal conditions

  6 months after surgery

• Increase in probing depth ≤ 1mm

  A parameter for monitoring periodontal conditions

  6 months after surgery

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

  A parameter for monitoring periodontal conditions

  6 months after surgery

Secondary Outcomes (14)

• Profilometric changes around the treated implant

  6 months after surgery

• Profilometric changes around the treated implant

  1 year after surgery

• Profilometric changes around the treated implant

  3 year after surgery

• Profilometric changes around the treated implant

  5 year after surgery

• Early wound healing

  1 month after surgery

Study Arms (3)

Subepithelial connective tissue group (SCTG)

ACTIVE COMPARATOR

A SCTG will be harvested from the patient's palate with a dimension dependent on the size of the peri-implant osseous defect. The technique of harvesting a soft tissue grafting is well described and established in the literature. Following the administration of local anesthesia, the SCTG will be harvested using a single incision technique. The periosteum will be left intact. The thickness of the SCTG will be at least 1.5mm. A cross suture will be used to close the palatal incision. The SCTG will be placed on the buccal exposed implant threads (above the DBBM-C) exceeding 1mm in a coronal and apical direction, 3mm in a mesial and distal direction and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.

Procedure: Subepithelial connective tissue

Volume stable Collagen Matrix group (VCMX)

ACTIVE COMPARATOR

A VMCX (FibroGide®) will be hydrated in sterile saline, trimmed and adjusted to a dimension dependent on the size of the osseous peri-implant defect. The VCMX will then be placed as described above and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.

Procedure: Volume stable Collagen Matrix

No soft tissue augmentation (GBR)

SHAM COMPARATOR

No barrier membranes will be placed. After filling the defect with the bone substitute, the flaps are closed primarily and tension-free following a horizontal periosteal releasing incision.

Procedure: No soft tissue augmentation

Interventions

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.

Subepithelial connective tissue group (SCTG)

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.

Volume stable Collagen Matrix group (VCMX)

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.

No soft tissue augmentation (GBR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nadja Naenni: lead

Study Sites (3)

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

Frankfurt, Germany

NOT YET RECRUITING

National Dental Centre Singapore

Singapore, Singapore

NOT YET RECRUITING

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

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nadja Naenni, Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolanta Boruta

CONTACT

+41446343260; jolanta.boruta@zzm.uzh.ch

Silvia Rasi, Dr.

CONTACT

+4144643365; silvia.rasi@zzm.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible for the intended interventions, as the harvest of the SCTG requires an additional surgical site at the palate, which will be recognized by the patient. The investigators will also be aware of the type of procedure, as both follow different operation procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. dent

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: October 31, 2022
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1); SG (1)