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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03163602




Registration number
NCT03163602
Ethics application status
Date submitted
14/04/2017
Date registered
23/05/2017
Date last updated
2/05/2018

Titles & IDs
Public title
Surgical Treatment of Peri-implantitis
Scientific title
Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.
Secondary ID [1] 0 0
15-116
Universal Trial Number (UTN)
Trial acronym
STP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-Implantitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Control group
Treatment: Devices - Test group

Active Comparator: Control Group 1 - Access flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days)

Active Comparator: Test Group 2 - 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®)


Treatment: Drugs: Control group
Access flap and debridement

Treatment: Devices: Test group
Regenerative treatment

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
resolution of peri-implantitis - no bleeding or suppuration on probing, no further bone loss, reduction in probing depth
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
probing depth change - mm
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
radiographic bone level change - mm
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
change in peri-implant soft tissue level - mm
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
patient reported outcomes - VAS scores
Timepoint [4] 0 0
1, 6, 12 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
The University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Osteology Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. Outcome measures will include
assessments of inflammation, probing depth, recession, radiological parameters and PROMs.
Trial website
https://clinicaltrials.gov/show/NCT03163602
Trial related presentations / 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. Review.
Heitz-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. Review.
Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennström 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.
Heitz-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.
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Heitz-Mayfield, OdontDr
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Heitz-Mayfield, Odont Dr
Address 0 0
Country 0 0
Phone 0 0
(+61 0861101686)
Fax 0 0
Email 0 0
heitz.mayfield@iinet.net.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03163602