Peri-ImplantitisSTPNCT03163602
Surgical Treatment of Peri-implantitis
A study testing Test group in people with Peri-Implantitis, run by The University of Western Australia at 1 site in Australia.
Trial summary
The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. 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?
- Test group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 15 May 2017to 6 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Presence of ≥ 1 implant with a probing depth (PD) ≥ 5 mm with bleeding and/or suppuration (SUP) on probing, and peri-implant bone loss ≥ 3mm with an intraosseous defect component
Who cannot join
- Smokers > 10 cigarettes per day
- Patients with uncontrolled diabetes mellitus
- Pregnant or lactating women (self reported)
- Patients with a systemic illness that preclude them from oral surgery
- Patients with an allergy to amoxicillin or metronidazole or chlorhexidine.
- Patients requiring antibiotic prophylaxis and Patients who have taken antibiotics in the past 3 months
Trial locations and contacts
1 site in 1 country.
Australia1 site
The University of Western Australia
Perth, Western Australia, 6009
About this study
Official title: Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.
The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.
Read the detailed description
The aim of this randomized controlled study is to evaluate the possible benefit of a regenerative treatment protocol (placing a bone substitute covered by a bioresorbable collagen membrane) compared to surgical treatment alone, for peri-implantitis therapy.
The hypothesis is that there will be a greater number of patients with successful treatment of peri-implantitis following the use of a bone substitute/collagen membrane compared to surgical peri-implantitis therapy without the bone substitute/collagen membrane.
The project will be conducted as a two-armed randomized controlled clinical trial of 1-year duration. Forty systemically healthy patients with ≥1 implant diagnosed with peri-implantitis requiring surgical therapy will be enrolled.
Baseline measurements will be performed after non-surgical therapy (removal supramucosal biofilm/calculus, oral hygiene instruction and correction of prosthetic factors) and treatment of periodontitis.
Baseline measurements will include probing depth, position of mucosal margin, presence of plaque, presence of bleeding and/or suppuration on probing, PROMs and radiographs. Measurements will be recorded at 4 sites per implant.
Following the baseline measurements participants will be randomly assigned to either Control Group (Group 1): access flap and implant cleaning or Test Group (Group 2): access flap, implant cleaning and addition of a bone substitute material covered by a collagen membrane.
Participants in both treatment groups will be prescribed systemic antimicrobials (Amoxicillin 500 mg tds and Metronidazole 400 mg tds) for 7 days starting from the day of surgery.
In addition an antibacterial mouthrinse (chlorhexidine digluconate 0.2%) will be prescribed for a period of 4 weeks following surgery.
Participants will be asked to attend follow-up visits for review of healing (week 1 and 4) and maintenance care (3, 6, 9, and 12 months).
Clinical examinations will be performed by a calibrated blinded examiner at baseline and 12 months after therapy. Clinical measurements will be taken using a periodontal probe at 4 sites per implant to record presence of plaque, bleeding, probing depth and recession of the soft tissue.
PROMS will be assessed at 1 week, 4 weeks and at 12 months. Radiographic assessments Intra-oral radiographs and cone beam CT scan will be obtained prior to surgery and at 12 months. Oral-maxillofacial radiologists will. perform the radiographic analysis and will be blinded to the treatment procedure.
Primary outcome variables include (1) resolution of peri-implantitis (probing depth reduction and absence of BoP, suppuration) (2) recurrence of disease (BoP, suppuration and increase in PPD and progression of bone loss.
- Conditions
- Peri-Implantitis
- Being tested
- Control group, Test group
- Keywords
- Peri-Implantitis, Infection, Bone substitutes
- Medical subject headings
- Peri-Implantitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
Also called Access flap and debridement
Access flap and debridement
Test groupDevice
Also called BioOss®, BioGide® collagen membrane
Regenerative treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | Active comparator | Access flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days) Receives: Drug: Control group |
| Test Group 2 | Active comparator | Access flap, implant surface debridement, systemic antibiotics (amoxicillin 500 mg, metronidazole 400 g, 3 x day for 7 days), bovine bone substitute material (BioOss®) and collagen membrane (BioGide®) Receives: Device: Test group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Success Outcome
Number of participants with treated implant with successful outcome: no bleeding or suppuration on probing, no further bone loss, PD ≤ 5 mm
Measured: 12 months
Secondary outcomes (4)
probing depth change
mm
Measured: 12 months
radiographic bone level change
mm
Measured: 12 months
change in peri-implant soft tissue level
mm
Measured: 12 months
patient reported outcomes
VAS scores
Measured: 1, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start15 May 2017
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Principal investigator, Lisa Heitz-Mayfield, The University of Western Australia
- Investigators
- Lisa Heitz-Mayfield, OdontDr, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163602
- Sponsor's protocol ID
- 15-116
- Acronym
- STP
- Status last verified
- Aug 2022
- First submitted
- 14 Apr 2017
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.
PubMed 22834392Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.
PubMed 24660207Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
PubMed 26285807Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.
PubMed 27335316Heitz-Mayfield LJA, Heitz F, Koong B, Huang T, Chivers P. Surgical peri-implantitis treatment with and without guided bone regeneration. A randomized controlled trial. Clin Oral Implants Res. 2023 Sep;34(9):892-910. doi: 10.1111/clr.14116. Epub 2023 Jun 29.
PubMed 37382408
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03163602
- Acronym / sponsor ID
- STP / 15-116
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis, Infection, Bone substitutes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 15 May 2017 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 23 May 2017 (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 aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.
Detailed description
The aim of this randomized controlled study is to evaluate the possible benefit of a regenerative treatment protocol (placing a bone substitute covered by a bioresorbable collagen membrane) compared to surgical treatment alone, for peri-implantitis therapy.
The hypothesis is that there will be a greater number of patients with successful treatment of peri-implantitis following the use of a bone substitute/collagen membrane compared to surgical peri-implantitis therapy without the bone substitute/collagen membrane.
The project will be conducted as a two-armed randomized controlled clinical trial of 1-year duration. Forty systemically healthy patients with ≥1 implant diagnosed with peri-implantitis requiring surgical therapy will be enrolled.
Baseline measurements will be performed after non-surgical therapy (removal supramucosal biofilm/calculus, oral hygiene instruction and correction of prosthetic factors) and treatment of periodontitis.
Baseline measurements will include probing depth, position of mucosal margin, presence of plaque, presence of bleeding and/or suppuration on probing, PROMs and radiographs. Measurements will be recorded at 4 sites per implant.
Following the baseline measurements participants will be randomly assigned to either Control Group (Group 1): access flap and implant cleaning or Test Group (Group 2): access flap, implant cleaning and addition of a bone substitute material covered by a collagen membrane.
Participants in both treatment groups will be prescribed systemic antimicrobials (Amoxicillin 500 mg tds and Metronidazole 400 mg tds) for 7 days starting from the day of surgery.
In addition an antibacterial mouthrinse (chlorhexidine digluconate 0.2%) will be prescribed for a period of 4 weeks following surgery.
Participants will be asked to attend follow-up visits for review of healing (week 1 and 4) and maintenance care (3, 6, 9, and 12 months).
Clinical examinations will be performed by a calibrated blinded examiner at baseline and 12 months after therapy. Clinical measurements will be taken using a periodontal probe at 4 sites per implant to record presence of plaque, bleeding, probing depth and recession of the soft tissue.
PROMS will be assessed at 1 week, 4 weeks and at 12 months. Radiographic assessments Intra-oral radiographs and cone beam CT scan will be obtained prior to surgery and at 12 months. Oral-maxillofacial radiologists will. perform the radiographic analysis and will be blinded to the treatment procedure.
Primary outcome variables include (1) resolution of peri-implantitis (probing depth reduction and absence of BoP, suppuration) (2) recurrence of disease (BoP, suppuration and increase in PPD and progression of bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | Active comparator | Drug: Control groupAccess flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days) |
| Test Group 2 | Active comparator | Device: Test groupAccess flap, implant surface debridement, systemic antibiotics (amoxicillin 500 mg, metronidazole 400 g, 3 x day for 7 days), bovine bone substitute material (BioOss®) and collagen membrane (BioGide®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of ≥ 1 implant with a probing depth (PD) ≥ 5 mm with bleeding and/or suppuration (SUP) on probing, and peri-implant bone loss ≥ 3mm with an intraosseous defect component
Key exclusion criteria (6 listed)
- Smokers > 10 cigarettes per day
- Patients with uncontrolled diabetes mellitus
- Pregnant or lactating women (self reported)
- Patients with a systemic illness that preclude them from oral surgery
- Patients with an allergy to amoxicillin or metronidazole or chlorhexidine.
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 |
|---|---|---|
| Control groupAlso: Access flap and debridementAccess flap and debridement | Drug | Control Group 1 |
| Test groupAlso: BioOss®, BioGide® collagen membraneRegenerative treatment | Device | Test Group 2 |
Primary outcome
Composite Success Outcome
Time frame: 12 months
Number of participants with treated implant with successful outcome: no bleeding or suppuration on probing, no further bone loss, PD ≤ 5 mm
4 secondary outcomes
probing depth change
Time frame: 12 months
radiographic bone level change
Time frame: 12 months
change in peri-implant soft tissue level
Time frame: 12 months
patient reported outcomes
Time frame: 1, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 22834392Esposito M, Grusovin MG, Worthington HV. Treatment of peri-implantitis: what interventions are effective? A Cochrane systematic review. Eur J Oral Implantol. 2012;5 Suppl:S21-41.
- Background: PubMed 24660207Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.
- Background: PubMed 26285807Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
- Background: PubMed 27335316Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.
- Derived from this study: PubMed 37382408Heitz-Mayfield LJA, Heitz F, Koong B, Huang T, Chivers P. Surgical peri-implantitis treatment with and without guided bone regeneration. A randomized controlled trial. Clin Oral Implants Res. 2023 Sep;34(9):892-910. doi: 10.1111/clr.14116. Epub 2023 Jun 29.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Lisa Heitz-Mayfield, OdontDr principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test group in people with Peri-Implantitis, run by The University of Western Australia at 1 site in Australia.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Success Outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163602, which also lists 5 linked publications.
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 5 Aug 2022.