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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: Subepithelial connective tissue; Procedure: Volume stable Collagen Matrix; Procedure: No soft tissue augmentation

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jolanta Boruta; Phone Number: +41446343260; Email: jolanta.boruta@zzm.uzh.ch
• Study Contact Backup: Name: Silvia Rasi, Dr.; Phone Number: +4144643365; Email: silvia.rasi@zzm.uzh.ch

Study Locations

• Germany
  • Frankfurt, Germany
    • Not yet recruiting
    • Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
    • Contact: Frank Schwarz, Prof.
• Singapore
  • Singapore, Singapore
    • Not yet recruiting
    • National Dental Centre Singapore
    • Contact: Wan Zhen Lee, Dr.
• Switzerland
  • Zürich, Switzerland
    • Recruiting
    • Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
    • Contact: Nadja Naenni, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	6 months after surgery
Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	1 year after surgery
Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	3 year after surgery
Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	5 year after surgery
Early wound healing	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	1 month after surgery
Early wound healing	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	2 month after surgery
Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	6 months after surgery
Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	1 year after surgery
Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	3 years after surgery
Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	5 years after surgery
Oral Health Impact Profile-14	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	6 months after surgery
Oral Health Impact Profile-14	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	1 year after surgery
Oral Health Impact Profile-14	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	3 years after surgery
Oral Health Impact Profile-14	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	5 years after surgery

Collaborators and Investigators

• Sponsor: Nadja Naenni
• Investigators: Principal Investigator: Nadja Naenni, Dr., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: collagen matrix; tissue augmentation of moderate-severe peri-implantitis; implantoplasty; autogenous connective tissue graft
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 2022 - 462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No