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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415111
• Other study ID #: 2022 - 462
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Jolanta Boruta
• Phone: +41446343260
• Email: jolanta.boruta[@]zzm.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt	Frankfurt
Singapore	National Dental Centre Singapore	Singapore
Switzerland	Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Nadja Naenni

Countries where clinical trial is conducted

Germany,  Singapore,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of bleeding/ suppuration on probing	A parameter for monitoring periodontal conditions	6 months after surgery
Primary	Increase in probing depth = 1mm	A parameter for monitoring periodontal conditions	6 months after surgery
Primary	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	Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	6 months after surgery
Secondary	Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	1 year after surgery
Secondary	Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	3 year after surgery
Secondary	Profilometric changes around the treated implant	The profilometric changes will be evaluated based on intra-oral scans	5 year after surgery
Secondary	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
Secondary	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
Secondary	Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	6 months after surgery
Secondary	Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	1 year after surgery
Secondary	Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	3 years after surgery
Secondary	Radiographic evaluation of the amount of hard tissue	evaluation of the marginal bone level changes	5 years after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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