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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants.
Study specific intervention is the placement of a 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.
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
Frankfurt, Germany
NOT_YET_RECRUITINGNational Dental Centre Singapore
Singapore, Singapore
NOT_YET_RECRUITINGClinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
Zurich, Switzerland
RECRUITINGAbsence of bleeding/ suppuration on probing
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
Increase in probing depth ≤ 1mm
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 6 months after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 1 year after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 3 year after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 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
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Time frame: 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
Time frame: 2 month after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Time frame: 6 months after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Time frame: 1 year after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Time frame: 3 years after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years after surgery