Peri-ImplantitisNCT05415111
The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis
A study testing Subepithelial connective tissue, Volume stable Collagen Matrix and No soft tissue augmentation in people with Peri-Implantitis, run by Nadja Naenni at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Subepithelial connective tissue, Volume stable Collagen Matrix and No soft tissue augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 31 Oct 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Good oral hygiene (full mouth plaque score <25%)
- Adequate control of inflammation (full mouth BOP <25%)
- Signed informed consent form
Who cannot join
- Pregnant or lactating female patient at inclusion
- Allergy or objection to porcine and bovine implantable biomaterials
- Allergy to Penicillin or NSAIDs
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
- Smoking > 15 cigarettes a day
- Active periodontal disease
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
Frankfurt
Frank Schwarz, Prof.
Singapore1 site, 1 recruiting
- Not yet recruiting
National Dental Centre Singapore
Singapore
Wan Zhen Lee, Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
Zurich
Nadja Naenni, Dr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- Subepithelial connective tissue, Volume stable Collagen Matrix, No soft tissue augmentation
- Keywords
- tissue augmentation of moderate-severe peri-implantitis, implantoplasty, collagen matrix, autogenous connective tissue graft
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subepithelial connective tissueProcedure or surgery
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 MatrixProcedure or surgery
Study specific intervention is the placement of a soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants.
No soft tissue augmentationProcedure or surgery
Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial connective tissue group (SCTG) | Active comparator | 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. Receives: Procedure: Subepithelial connective tissue |
| Volume stable Collagen Matrix group (VCMX) | Active comparator | 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. Receives: Procedure: Volume stable Collagen Matrix |
| No soft tissue augmentation (GBR) | Sham comparator | 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. Receives: Procedure: No soft tissue augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of bleeding/ suppuration on probing
A parameter for monitoring periodontal conditions
Measured: 6 months after surgery
Increase in probing depth ≤ 1mm
A parameter for monitoring periodontal conditions
Measured: 6 months after surgery
Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
A parameter for monitoring periodontal conditions
Measured: 6 months after surgery
Secondary outcomes (14)
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Measured: 6 months after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Measured: 1 year after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Measured: 3 year after surgery
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Measured: 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
Measured: 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
Measured: 2 month after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Measured: 6 months after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Measured: 1 year after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Measured: 3 years after surgery
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start31 Oct 2022
- Primary completionMar 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) or 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. The bone graft will remain permanently in the patients.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadja Naenni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadja Naenni, University of Zurich
- Investigators
- Nadja Naenni, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415111
- Sponsor's protocol ID
- 2022 - 462
- Status last verified
- May 2024
- First submitted
- 8 Jun 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Soft Tissue Augmentation Procedures on the Surgical Treatment of Moderate-severe Peri-implantitis: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05415111
- Acronym / sponsor ID
- 2022 - 462
- Conditions
- Peri-Implantitis
- Keywords
- tissue augmentation of moderate-severe peri-implantitis, implantoplasty, collagen matrix, autogenous connective tissue graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nadja NaenniUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) or 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. The bone graft will remain permanently in the patients.
| Arm | Type | Receives |
|---|---|---|
| Subepithelial connective tissue group (SCTG) | Active comparator | Procedure: Subepithelial connective tissueA 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. |
| Volume stable Collagen Matrix group (VCMX) | Active comparator | Procedure: Volume stable Collagen MatrixA 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. |
| No soft tissue augmentation (GBR) | Sham comparator | Procedure: No soft tissue augmentationNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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%)
Key exclusion criteria (7 listed)
- Pregnant or lactating female patient at inclusion
- Allergy or objection to porcine and bovine implantable biomaterials
- Allergy to Penicillin or NSAIDs
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subepithelial connective tissueStudy specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants. | Procedure or surgery | Subepithelial connective tissue group (SCTG) |
| Volume stable Collagen MatrixStudy specific intervention is the placement of a soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants. | Procedure or surgery | Volume stable Collagen Matrix group (VCMX) |
| No soft tissue augmentationStudy specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed. | Procedure or surgery | No soft tissue augmentation (GBR) |
Primary outcome
Absence of bleeding/ suppuration on probing
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
Increase in probing depth ≤ 1mm
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
Time frame: 6 months after surgery
A parameter for monitoring periodontal conditions
14 secondary outcomes
Profilometric changes around the treated implant
Time frame: 6 months after surgery
Profilometric changes around the treated implant
Time frame: 1 year after surgery
Profilometric changes around the treated implant
Time frame: 3 year after surgery
Profilometric changes around the treated implant
Time frame: 5 year after surgery
Early wound healing
Time frame: 1 month after surgery
Early wound healing
Time frame: 2 month after surgery
Radiographic evaluation of the amount of hard tissue
Time frame: 6 months after surgery
Radiographic evaluation of the amount of hard tissue
Time frame: 1 year after surgery
Radiographic evaluation of the amount of hard tissue
Time frame: 3 years after surgery
Radiographic evaluation of the amount of hard tissue
Time frame: 5 years after surgery
Oral Health Impact Profile-14
Time frame: 6 months after surgery
Oral Health Impact Profile-14
Time frame: 1 year after surgery
Oral Health Impact Profile-14
Time frame: 3 years after surgery
Oral Health Impact Profile-14
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadja Naenni, Dr. principal investigator
University of Zurich
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subepithelial connective tissue, Volume stable Collagen Matrix and No soft tissue augmentation in people with Peri-Implantitis, run by Nadja Naenni at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Singapore, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jolanta Boruta (+41446343260, jolanta.boruta@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of bleeding/ suppuration on probing (time frame: 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.