Peri-ImplantitisSPiT-freqvzyNCT04705012
SPiT-frequency; the Effect of Increased Frequency of Intervention on Post-surgical Peri-implant Inflammation
A study testing Submucosal supportive therapy in people with Peri-Implantitis, run by University of Oslo.
Trial summary
This pilot study is an interventional clinical study on the supportive peri-implant treatment (SPiT) necessary to maintain/ improve the clinical conditions surrounding a dental implant following surgical treatment of peri-implantitis. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Submucosal supportive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 20 years,
- Subjects must have received surgical treatment of peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018).
- Subjects have to present inflammation (suppuration or BoP 3-2) at more than one implant of similar implant brand, with similar defect type (Schwarz et al., 2007), and defect severity.
- The implants must not be replacing adjacent teeth (minimum space for one tooth/implant between test and control.
Who cannot join
- • Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.
- No pregnant or nursing subjects.
- < class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.
- Registered implant bone loss with exposed modified surface < 2.0 mm.
- If examiners/operators agree the placement of the implant (angle, position, proximity to adjacent implant or tooth) or suprastructure was suboptimal and considered to play a major role in the development and sustain the peri-implant disease.
- Anatomical abnormalities
Show all 10Show fewer
- clinical exclusion criteria specific to the disease/condition
- specific concomitant treatment with other devise, mouthrinse or systemic antibiotics
- participation in any other clinical study within the last month
- inability to comprehend and respond to the quality of life questionnaire
About this study
Official title: SPiT-frequency; the Effect of Increased Frequency of Intervention, Using Chitosan Brushes, on Post-surgical Peri-implant Inflammation
This pilot study is an interventional clinical study on the supportive peri-implant treatment (SPiT) necessary to maintain/ improve the clinical conditions surrounding a dental implant following surgical treatment of peri-implantitis. The focus of this pilot, double arm, split-mouth, single centre, controlled, randomised clinical study is to examine the effect of short-term increased frequency of a SPiT-protocol.
Read the detailed description
Patients with surgically treated peri-implantitis enrolled in a maintenance program at the Specialist clinic, Institute for Clinical Dentistry, Dental Faculty, University of Oslo, will receive SPiT by the use of an oscillating chitosan brush (LBC, BioClean, Labrida AS, Oslo, Norway). Subjects with at least two not-adjacent implants of similar brand and defect configuration registered with suppuration or Bleeding index score 3-2 (Roos-Jansaker et al., 2007) on at least 1 of 6 surfaces (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) will be invited to participate in the current pilot study.
Baseline examinations and treatment:
Radiographs of the implants showing clear projections of the implant threads at the mesial and distal surfaces will be taken using standard Eggens holders
The following clinical registrations will be performed at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) of the included implants by the blinded examiner:
Suppuration: the presence or absence after light pressure against gingiva/mucosa or following gentle probing of the peri-implant pocket.
Plaque: the presence or absence recognized by running a probe across the marginal surface of the implant (Mombelli, van Oosten, Jr, \& Lang, 1987).
Gingival bleeding: registered according to the Modified Sulcus Bleeding Index (mBI) (Mombelli et al., 1987).
PPD: recorded with a pressure- sensitive probe (20 g) (University of North Carolina probe, Aesculap, Braun, Tuttlingen, Germany).
Bleeding index score: measured at the implants after probing at six sites, and graded (0-3):
0 = no bleeding,
- = spot bleeding,
- = line bleeding
- = profound bleeding within 30 seconds after measurement of PPD. Presence of keratinized mucosa: registered at the mid buccal site as "adequate" ≥2 mm, "inadequate" <2 mm (Moraschini, Luz, Velloso, \& Barboza, 2017).
All included implants receive the following treatment:
Repeated oral hygiene instruction if needed Submucosal debridement with a chitosan brush (LBC, BioClean®, LABRIDA AS, Oslo, Norway) seated in an oscillating dental drill piece (ER10M, TEQ-Y, NSK Inc., Kanuma Tochigi, Japan) for 3 min followed by copious irrigation with sterile saline Supramucosal polishing using polishing paste and rubber cup Following treatment, if local anesthesia was not applied, the subjects will be asked to grade the level of pain experienced on a 10 cm visual analogue scale (VAS).
3-, 6- and 9 weeks following baseline At the 3-week follow up, an equal number of included implants are determined "test-" and "control-" by flipping of a coin.
At these time points, all implants are clinically examined by a blinded examiner and receive supramucosal polishing, but only test-implants receive submucosal debridement as described above (see figure 1) VAS scales are registered
12 weeks (3 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered
16 weeks (4 month) following baseline All implants are clinically examined by a blinded examiner and receive supramucosal polishing, but only test-implants receive submucosal debridement as described above (see figure 1) VAS scales are registered
24 weeks (6 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered
36 weeks (9 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered Radiographs are taken according to the baseline examination
Figure 1: Timeline of the clinical trial
- Conditions
- Peri-Implantitis
- Being tested
- Submucosal supportive therapy
- Keywords
- SPiT
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal supportive therapyOther
Increased frequency of submucosal cleaning using a rotating chitosan brush
| Study group | Role | What they receive |
|---|---|---|
| Test - increased frequency of submucosal cleaning | Experimental | At follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above Receives: Other: Submucosal supportive therapy |
| Control - conventional frequency of submucosal cleaning | Active comparator | At follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above Receives: Other: Submucosal supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of disease
Proportion of implants without signs of inflammation defined as BoP and/or suppuration (eradication of disease)
Measured: 9 months
Secondary outcomes (4)
Reduction in inflammation,
changes in severity of inflammation (inflammation assessed as Bleeding index 3, 2 or 1 (Roos-Jansaker et al., 2007)
Measured: 9 months
Radiographic changes
progressive bone loss as measured on radiographs
Measured: 9 months
Morbidity, patient centered outcomes
patient experience of pain in relation to treatment
Measured: 9 month
Implant survival
implant present at examination
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jan 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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
- Examiner blinded split-mouth clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odd Carsten Koldsland, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705012
- Sponsor's protocol ID
- 195347
- Acronym
- SPiT-freqvzy
- Status last verified
- Nov 2022
- First submitted
- 17 Dec 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPiT-frequency; the Effect of Increased Frequency of Intervention, Using Chitosan Brushes, on Post-surgical Peri-implant Inflammation
- ClinicalTrials.gov ID
- NCT04705012
- Acronym / sponsor ID
- SPiT-freqvzy / 195347
- Conditions
- Peri-Implantitis
- Keywords
- SPiT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Jan 2021 (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.
This pilot study is an interventional clinical study on the supportive peri-implant treatment (SPiT) necessary to maintain/ improve the clinical conditions surrounding a dental implant following surgical treatment of peri-implantitis. The focus of this pilot, double arm, split-mouth, single centre, controlled, randomised clinical study is to examine the effect of short-term increased frequency of a SPiT-protocol.
Detailed description
Patients with surgically treated peri-implantitis enrolled in a maintenance program at the Specialist clinic, Institute for Clinical Dentistry, Dental Faculty, University of Oslo, will receive SPiT by the use of an oscillating chitosan brush (LBC, BioClean, Labrida AS, Oslo, Norway). Subjects with at least two not-adjacent implants of similar brand and defect configuration registered with suppuration or Bleeding index score 3-2 (Roos-Jansaker et al., 2007) on at least 1 of 6 surfaces (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) will be invited to participate in the current pilot study.
Baseline examinations and treatment:
Radiographs of the implants showing clear projections of the implant threads at the mesial and distal surfaces will be taken using standard Eggens holders
The following clinical registrations will be performed at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) of the included implants by the blinded examiner:
Suppuration: the presence or absence after light pressure against gingiva/mucosa or following gentle probing of the peri-implant pocket.
Plaque: the presence or absence recognized by running a probe across the marginal surface of the implant (Mombelli, van Oosten, Jr, \& Lang, 1987).
Gingival bleeding: registered according to the Modified Sulcus Bleeding Index (mBI) (Mombelli et al., 1987).
PPD: recorded with a pressure- sensitive probe (20 g) (University of North Carolina probe, Aesculap, Braun, Tuttlingen, Germany).
Bleeding index score: measured at the implants after probing at six sites, and graded (0-3):
0 = no bleeding,
- = spot bleeding,
- = line bleeding
- = profound bleeding within 30 seconds after measurement of PPD. Presence of keratinized mucosa: registered at the mid buccal site as "adequate" ≥2 mm, "inadequate" <2 mm (Moraschini, Luz, Velloso, \& Barboza, 2017).
All included implants receive the following treatment:
Repeated oral hygiene instruction if needed Submucosal debridement with a chitosan brush (LBC, BioClean®, LABRIDA AS, Oslo, Norway) seated in an oscillating dental drill piece (ER10M, TEQ-Y, NSK Inc., Kanuma Tochigi, Japan) for 3 min followed by copious irrigation with sterile saline Supramucosal polishing using polishing paste and rubber cup Following treatment, if local anesthesia was not applied, the subjects will be asked to grade the level of pain experienced on a 10 cm visual analogue scale (VAS).
3-, 6- and 9 weeks following baseline At the 3-week follow up, an equal number of included implants are determined "test-" and "control-" by flipping of a coin.
At these time points, all implants are clinically examined by a blinded examiner and receive supramucosal polishing, but only test-implants receive submucosal debridement as described above (see figure 1) VAS scales are registered
12 weeks (3 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered
16 weeks (4 month) following baseline All implants are clinically examined by a blinded examiner and receive supramucosal polishing, but only test-implants receive submucosal debridement as described above (see figure 1) VAS scales are registered
24 weeks (6 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered
36 weeks (9 month) following baseline At these time point, all implants are clinically examined by a blinded examiner and receive supramucosal polishing as well as submucosal debridement as described above (see figure 1) VAS scales are registered Radiographs are taken according to the baseline examination
Figure 1: Timeline of the clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Examiner blinded split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test - increased frequency of submucosal cleaning | Experimental | Other: Submucosal supportive therapyAt follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above |
| Control - conventional frequency of submucosal cleaning | Active comparator | Other: Submucosal supportive therapyAt follow-up time points (3-, 6-, 9-, 16 weeks) following initial treatment), all implants receive supramucosal polishing, but only test-implants receive submucosal debridement 12 + 24 +36 weeks following baseline: all implants receive supramucosal polishing as well as submucosal debridement as described above |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be ≥ 20 years,
- Subjects must have received surgical treatment of peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018).
- Subjects have to present inflammation (suppuration or BoP 3-2) at more than one implant of similar implant brand, with similar defect type (Schwarz et al., 2007), and defect severity.
- The implants must not be replacing adjacent teeth (minimum space for one tooth/implant between test and control.
Key exclusion criteria (10 listed)
- • Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.
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 |
|---|---|---|
| Submucosal supportive therapyIncreased frequency of submucosal cleaning using a rotating chitosan brush | Other | Control - conventional frequency of submucosal cleaning, Test - increased frequency of submucosal cleaning |
Primary outcome
Eradication of disease
Time frame: 9 months
Proportion of implants without signs of inflammation defined as BoP and/or suppuration (eradication of disease)
4 secondary outcomes
Reduction in inflammation,
Time frame: 9 months
Radiographic changes
Time frame: 9 months
Morbidity, patient centered outcomes
Time frame: 9 month
Implant survival
Time frame: 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal supportive therapy in people with Peri-Implantitis, run by University of Oslo.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Eradication of disease (time frame: 9 months). 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 3 Nov 2022.