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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03163602
Ethics application status
Date submitted
14/04/2017
Date registered
23/05/2017
Date last updated
5/08/2022

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
Composite Success Outcome
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
probing depth change
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
radiographic bone level change
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
change in peri-implant soft tissue level
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
patient reported outcomes
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/09/2021
Sample size
Target
Accrual to date
Final
40
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/study/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.
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.
Carcuac 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.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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