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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
NOT_YET_RECRUITING
Frankfurt
Singapore
National Dental Centre Singapore
NOT_YET_RECRUITING
Singapore
Switzerland
Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
RECRUITING
Zurich
Contact Information
Primary
Jolanta Boruta
jolanta.boruta@zzm.uzh.ch
+41446343260
Backup
Silvia Rasi, Dr.
silvia.rasi@zzm.uzh.ch
+4144643365
Time Frame
Start Date: 2022-10-31
Estimated Completion Date: 2029-12
Participants
Target number of participants: 120
Treatments
Active_comparator: Subepithelial connective tissue group (SCTG)
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.
Active_comparator: Volume stable Collagen Matrix group (VCMX)
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.
Sham_comparator: No soft tissue augmentation (GBR)
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.
Related Therapeutic Areas
Sponsors
Leads: Nadja Naenni

This content was sourced from clinicaltrials.gov