Peri-ImplantitisNCT04152668
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing
A study testing Titanium curette., Ultrasonic and Air-polishing in people with Peri-Implantitis, run by Knut N. Leknes at 2 sites in Norway.
Trial summary
Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Titanium curette., Ultrasonic and Air-polishing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Dec 2021to 15 May 2022
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction
- Diagnosed with peri-implantitis based on the following criteria:
- Bleeding and/or suppuration upon gentle probing
- Increased probing depths (PD) compared with previous examinations or PD of ≥ 4 mm in at least one site around the implant
- Crestal bone level (CBL) loss ≥2 mm compared with baseline registration
Who cannot join
- Surgical treatment of peri-implantitis the last 6 months
- Supportive periodontal therapy within 3 months
- Use of systemic antibiotic within 6 months
- A history of non-compliant behavior
- Inflammation around implant without evidence of bone loss
- Periapical peri-implantitis
Show all 10Show fewer
- Subjects with implant fracture, ceramic implants, or detectable subgingival cement
- Any current medical condition affecting the use of the abrasive air-polishing device.
- Subjects with diabetes mellitus, cancer, HIV/aids, acute infections, liver or kidney dysfunction/failure,
- Current pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial
Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.
Read the detailed description
This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included.
Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.
In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.
- Conditions
- Peri-Implantitis
- Being tested
- Titanium curette., Ultrasonic, Air-polishing
- Keywords
- Peri-implantitis, Air-polishing, Erythritol
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium curette.Procedure or surgery
Implant debridement.
UltrasonicProcedure or surgery
Also called Ultrasonic device
Implant debridement.
Air-polishingProcedure or surgery
Also called Air-polishing device
Implant debridement and polishing.
| Study group | Role | What they receive |
|---|---|---|
| Titanium curette and ultrasonic. | Active comparator | Control implants will be debrided with titanium curette and ultrasonic device without time limit. Receives: Procedure: Titanium curette.; Procedure: Ultrasonic |
| Titanium curette, ultrasonic and air-polishing. | Experimental | Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit. Receives: Procedure: Titanium curette.; Procedure: Ultrasonic; Procedure: Air-polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in probing depth (PD)
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
Measured: 12 moths
Crestal bone level (CBL)
Intraoral digitalized radiographs will be taken with customized Eggen-holder and long cone, parallel technique to assess CBL. The distance from implant platform to the mesial and distal bone levels will be measured by using the software program DIGORA (Soredex, Helsinki).
Measured: 12 months
Secondary outcomes (3)
Bleeding on probing (BoP)
BoP as the presence of bleeding after gentle probing (Renvert et al. 2017).
Measured: 12 months
Gingival crevicular fluid (GCF)
Sample sites will be isolated with cottons rolls, carefully cleaned for supragingival plaque and air-dried. A perio paper strip will then be gently placed one to two mm into the entrance of the pocket and left in place for 30 seconds.
Measured: 12 months
Visual analogue scale (VAS)
The scorings will be performed following completion of the debridement at baseline and at 6 and 12 months with 0 = "no pain" and 100 = "worst pain I can imagine".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Dec 2021
- Primary completion28 Mar 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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, single-masked controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knut N. Leknes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Knut N. Leknes, University of Bergen
- Investigators
- Knut N. Leknes, Professor, Principal investigator, Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152668
- Sponsor's protocol ID
- UiB, IKO 2019
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Citations to publications related to the protocol: Background and Material and Methods.
Selimovic A, Bunaes DF, Lie SA, Lobekk MA, Leknes KN. Non-surgical treatment of peri-implantitis with and without erythritol air-polishing a 12-month randomized controlled trial. BMC Oral Health. 2023 Apr 24;23(1):240. doi: 10.1186/s12903-023-02973-5.
PubMed 37095488
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04152668
- Acronym / sponsor ID
- UiB, IKO 2019
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis, Air-polishing, Erythritol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Knut N. LeknesUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 5 Nov 2019 (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.
Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.
Detailed description
This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included.
Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.
In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-masked controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Titanium curette and ultrasonic. | Active comparator | Procedure: Titanium curette., Procedure: UltrasonicControl implants will be debrided with titanium curette and ultrasonic device without time limit. |
| Titanium curette, ultrasonic and air-polishing. | Experimental | Procedure: Titanium curette., Procedure: Ultrasonic, Procedure: Air-polishingTest implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction
- Diagnosed with peri-implantitis based on the following criteria:
Key exclusion criteria (10 listed)
- Surgical treatment of peri-implantitis the last 6 months
- Supportive periodontal therapy within 3 months
- Use of systemic antibiotic within 6 months
- A history of non-compliant behavior
- Inflammation around implant without evidence of bone loss
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 |
|---|---|---|
| Titanium curette.Implant debridement. | Procedure or surgery | Titanium curette and ultrasonic., Titanium curette, ultrasonic and air-polishing. |
| UltrasonicAlso: Ultrasonic deviceImplant debridement. | Procedure or surgery | Titanium curette and ultrasonic., Titanium curette, ultrasonic and air-polishing. |
| Air-polishingAlso: Air-polishing deviceImplant debridement and polishing. | Procedure or surgery | Titanium curette, ultrasonic and air-polishing. |
Primary outcome
Changes in probing depth (PD)
Time frame: 12 moths
PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites;
Crestal bone level (CBL)
Time frame: 12 months
Intraoral digitalized radiographs will be taken with customized Eggen-holder and long cone, parallel technique to assess CBL. The distance from implant platform to the mesial and distal bone levels will be measured by using the software program DIGORA (Soredex, Helsinki).
3 secondary outcomes
Bleeding on probing (BoP)
Time frame: 12 months
Gingival crevicular fluid (GCF)
Time frame: 12 months
Visual analogue scale (VAS)
Time frame: 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 14 Nov 2022.
- BackgroundCitations to publications related to the protocol: Background and Material and Methods.
- Derived from this study: PubMed 37095488Selimovic A, Bunaes DF, Lie SA, Lobekk MA, Leknes KN. Non-surgical treatment of peri-implantitis with and without erythritol air-polishing a 12-month randomized controlled trial. BMC Oral Health. 2023 Apr 24;23(1):240. doi: 10.1186/s12903-023-02973-5.
- 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. This study is not recruiting at the moment.
Knut N. Leknes, Professor principal investigator
Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium curette., Ultrasonic and Air-polishing in people with Peri-Implantitis, run by Knut N. Leknes at 2 sites in Norway.
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 5 inclusion and 10 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Changes in probing depth (PD) (time frame: 12 moths). The study lists 2 primary outcomes in all. 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 NCT04152668, which also lists 2 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 14 Nov 2022.