Subepithelial connective tissue
ProcedureStudy specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants.
NCT Number: NCT05415111
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt, Frankfurt, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
Time frame: 6 months after surgery
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 1 year after surgery
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 3 year after surgery
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 5 year after surgery
The profilometric changes will be evaluated based on intra-oral scans
Time frame: 1 month after surgery
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
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: 6 months after surgery
evaluation of the marginal bone level changes
Time frame: 1 year after surgery
evaluation of the marginal bone level changes
Time frame: 3 years after surgery
evaluation of the marginal bone level changes
Time frame: 5 years after surgery
evaluation of the marginal bone level changes
Time frame: 6 months after surgery
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: 1 year after surgery
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: 3 years after surgery
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
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
Contact information is provided by the study sponsor or research team.
Jolanta Boruta
CONTACT
Silvia Rasi, Dr.
CONTACT
Nadja Naenni
Other
The Adjunctive Effect of Soft Tissue Augmentation Procedures on the Surgical Treatment of Moderate-severe Peri-implantitis: A Randomized Controlled Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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