PeriodontitisNCT05757921
Comparison of Adjunctive Chemomechanical Therapy With Standard Care in Patients With Periodontitis
A study testing Perisolv (A) and Standard (B) in people with Periodontitis, run by Kristianstad University.
Trial summary
The goal of the clinical trial is to compare adjunctive chemomechanical therapy with standard care regarding root planning in patients with periodontitis. The primary outcome is to measure pocket depth before and after treatment in the test, and control group respectively Secondary outcomes: Bleeding on probing Plaque… Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Perisolv (A) and Standard (B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2011to 16 May 2014
- 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 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who agree to participate in the study and who also have at least 4 gingival pockets with probing depth ≥5 mm and which at the same time bleed on probing.
- -
Who cannot join
- Individuals with uncontrolled/difficult diabetes mellitus (HbA1c > 7.0)
- Individuals who need antibiotic prophylaxis
- Individuals taking medication with Prednisolone.
- Individuals taking medication that has a known side effect, gingival hyperplasia
- Individuals who took systemic antibiotics 3 months before the start of the study.
About this study
Official title: Non-surgical Treatment of Periodontitis With or Without the Adjunctive Treatment of Perisolv®
The goal of the clinical trial is to compare adjunctive chemomechanical therapy with standard care regarding root planning in patients with periodontitis. The primary outcome is to measure pocket depth before and after treatment in the test, and control group respectively
Secondary outcomes:
- Bleeding on probing
- Plaque index
- Quality of life from standardized protocol
The hypothesis is that non- surgical mechanical treatment with chloramines in patients with periodontitis will show a better pocket closure after the treatment.
Read the detailed description
Data from the clinical treatment were registered in patient records. In parallel, clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinic.The protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as, principal investigator and statisticians.
Variables used in the study originates from an international working group in periodontology in 2018 (Papapanou PN, et al 2018). In accordance with the working group diagnosis of periodontitis should include pocket depth, bleeding, and bone loss (X-ray). Thus, in this study the primary outcomes were pocket depth and bleeding on probing.
To compare scaling and root planning in periodontitis with an adjunctive application to enhance the standard care; an active comparator (Control group) was compared with an experimental arm (Test group).
Patients were therefore randomized into a test or control group. Inclusion criteria
- At least four pathological pockets ≥ 5 mm and bleeding on probing Exclusion criteria
- Diabetes HbA1c >7.0, antibiotics 3 months before treatment, cortisone treatment and if needed prophylactic antibiotics
Patients that participated in the study were consecutively given an ID code. Data was collected and registered in the ordinary patient journal. Journal entry and a research protocol was used with the unique ID number as to prevent breaches of privacy. The dental hygienist performed the treatments and was therfore not blinded. The periodontologists performed the primary and secondary outcomes within the clinical study were both blinded. The code list with the actual treatment was secured in a locked up space, at the clinic. Upon the final appointment the specific arm of treatment was registered by the dental hygienist in the patient journal. To ensure that the data from the study were correctly registered three independent dental nurses were validating the data separately.
All patients were given oral and written information about the study and signed a written informed consent. The patients were informed that they could drop off whenever they wanted without any explanations. The ethical board approved the study.
From a standard operation procedure by good clinical practice and Swedish legislation (The national board of social affairs and health and Health and Medical Care Act), the control group was exposed to mechanical non-surgical treatment in addition with oral hygiene instructions at baseline, 3 months, and 12 months. In the test group the same standard operation procedure was performed with the addition of Perisolv® in all pathological pockets ≥ 4 mm. Perisolv® was added initially and directly after the treatment. At all-time points both primary and secondary outcomes were determined for all pockets. In addition, the instrument Oral Health Impact Profile (OHIP) was used as a measurement of quality of life.
Risk assessments was handled by the safety regulation and quality plan of the clinic.The clinic followed the Swedish legalisation, Health and Medical Care Act with quality assurance. If any adverse events during the treatments the local standard operation procedures ensured reporting to concerned authority in Sweden. Participant not fulfilling the study was reported in the patient journal as not completed and statistically noted as missing data.
Regarding the study's safety plan any adverse event during the treatment code list would be decoded and would be covered by the dental insurance.
From the power analysis 32 individuals were minimum to reach a clinically significant difference at 0.5 mm between the groups with alpha 0.05 and power 80%. The IBM SPSS version 27.0 statistical software package (SPSS Inc., Armonk, NY, USA) for personal computer was used in the statistical analyses. Statistics was calculated as means with standard deviation (SD). Independent t-tests (equal variance not assumed) paired t-test and one-way ANOVA test were used to compare inter and intra-group differences. Non-parametric chi-square test was used for categorical variables. Statistical significance was set with 80 percent at p < 0.05. Non visits were recorded as missing data in the statistics.
- Conditions
- Periodontitis
- Being tested
- Perisolv (A), Standard (B)
- Keywords
- probing pocket depth, bleeding on probing, dental plaque
- Medical subject headings
- Periodontitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perisolv (A)Device
Intended for cleaning periodontal pockets for both periodontitis and peri-implantitis. Softens degenerative tissue and biofilm before depuration of periodontal pockets. Does not affect healthy tissue.
Standard (B)Other
Deepened periodontal pockets to be treated are performed by subgingivally debridement. This is performed with piezoelectric ultrasound (EMS) under rinsing water and subgingival debridement with hand instrument.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical mechanical treatment with Perisolv® (A) | Experimental | The test group will receive the following treatment: In the deepened pockets to be treated, Perisolv is initially applied according to the manufacturers recommendation.Then subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation. In addition an aliquot of Perisolv was left after final debridement. Receives: Device: Perisolv (A) |
| Non-surgical mechanical treatment without Perisolv® (B) | Active comparator | The control group will receive the following treatment: In the deepened pockets to be treated, subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation. Receives: Other: Standard (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
millimeter
Measured: baseline
probing pocket depth
millimeter
Measured: 3 months
probing pocket depth
millimeter
Measured: 12 months
Secondary outcomes (6)
bleeding on probing
percent
Measured: baseline
bleeding on probing
percent
Measured: 3 months
bleeding on probing
percent
Measured: 12 months
plaque index
percent
Measured: baseline
plaque index
percent
Measured: 3 months
plaque index
percent
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 posted7 Mar 2023
- Study start24 Oct 2011
- Primary completion16 May 2014
- Study completion16 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Test group: non-surgical mechanical treatment and adjunctive treatment Perisolv Control group: non-surgical mechanical treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristianstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viveca Wallin Bengtsson, Kristianstad University
- Investigators
- Ann-Marie AJ Roos Jansaker, Assoc.Prof., Principal investigator, Kristianstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757921
- Sponsor's protocol ID
- Peri_Solv
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smiley CJ, Tracy SL, Abt E, Michalowicz BS, John MT, Gunsolley J, Cobb CM, Rossmann J, Harrel SK, Forrest JL, Hujoel PP, Noraian KW, Greenwell H, Frantsve-Hawley J, Estrich C, Hanson N. Systematic review and meta-analysis on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015 Jul;146(7):508-24.e5. doi: 10.1016/j.adaj.2015.01.028.
PubMed 26113099Ferreira MC, Dias-Pereira AC, Branco-de-Almeida LS, Martins CC, Paiva SM. Impact of periodontal disease on quality of life: a systematic review. J Periodontal Res. 2017 Aug;52(4):651-665. doi: 10.1111/jre.12436. Epub 2017 Feb 8.
PubMed 28177120Citterio F, Gualini G, Chang M, Piccoli GM, Giraudi M, Manavella V, Baima G, Mariani GM, Romano F, Aimetti M. Pocket closure and residual pockets after non-surgical periodontal therapy: A systematic review and meta-analysis. J Clin Periodontol. 2022 Jan;49(1):2-14. doi: 10.1111/jcpe.13547. Epub 2021 Nov 11.
PubMed 34517433Jepsen K, Jepsen S. Antibiotics/antimicrobials: systemic and local administration in the therapy of mild to moderately advanced periodontitis. Periodontol 2000. 2016 Jun;71(1):82-112. doi: 10.1111/prd.12121.
PubMed 27045432Guida A. Mechanism of action of sodium hypochlorite and its effects on dentin. Minerva Stomatol. 2006 Sep;55(9):471-82. English, Italian.
PubMed 17146426Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
PubMed 29926951Wallin-Bengtsson V, Scherdin-Almhojd U, Roos-Jansaker AM. Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine - a one-year randomized clinical trial study. Acta Odontol Scand. 2024 Mar 22;83:1-6. doi: 10.1080/00016357.2023.2281486.
PubMed 37962876
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Periodontitis With or Without the Adjunctive Treatment of Perisolv®
- ClinicalTrials.gov ID
- NCT05757921
- Acronym / sponsor ID
- Peri_Solv
- Conditions
- Periodontitis
- Keywords
- probing pocket depth, bleeding on probing, dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kristianstad UniversityUniversity, hospital or other
- Study start
- 24 Oct 2011 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 May 2014 (actual)
- First posted
- 7 Mar 2023 (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 goal of the clinical trial is to compare adjunctive chemomechanical therapy with standard care regarding root planning in patients with periodontitis. The primary outcome is to measure pocket depth before and after treatment in the test, and control group respectively
Secondary outcomes:
- Bleeding on probing
- Plaque index
- Quality of life from standardized protocol
The hypothesis is that non- surgical mechanical treatment with chloramines in patients with periodontitis will show a better pocket closure after the treatment.
Detailed description
Data from the clinical treatment were registered in patient records. In parallel, clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinic.The protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as, principal investigator and statisticians.
Variables used in the study originates from an international working group in periodontology in 2018 (Papapanou PN, et al 2018). In accordance with the working group diagnosis of periodontitis should include pocket depth, bleeding, and bone loss (X-ray). Thus, in this study the primary outcomes were pocket depth and bleeding on probing.
To compare scaling and root planning in periodontitis with an adjunctive application to enhance the standard care; an active comparator (Control group) was compared with an experimental arm (Test group).
Patients were therefore randomized into a test or control group. Inclusion criteria
- At least four pathological pockets ≥ 5 mm and bleeding on probing Exclusion criteria
- Diabetes HbA1c >7.0, antibiotics 3 months before treatment, cortisone treatment and if needed prophylactic antibiotics
Patients that participated in the study were consecutively given an ID code. Data was collected and registered in the ordinary patient journal. Journal entry and a research protocol was used with the unique ID number as to prevent breaches of privacy. The dental hygienist performed the treatments and was therfore not blinded. The periodontologists performed the primary and secondary outcomes within the clinical study were both blinded. The code list with the actual treatment was secured in a locked up space, at the clinic. Upon the final appointment the specific arm of treatment was registered by the dental hygienist in the patient journal. To ensure that the data from the study were correctly registered three independent dental nurses were validating the data separately.
All patients were given oral and written information about the study and signed a written informed consent. The patients were informed that they could drop off whenever they wanted without any explanations. The ethical board approved the study.
From a standard operation procedure by good clinical practice and Swedish legislation (The national board of social affairs and health and Health and Medical Care Act), the control group was exposed to mechanical non-surgical treatment in addition with oral hygiene instructions at baseline, 3 months, and 12 months. In the test group the same standard operation procedure was performed with the addition of Perisolv® in all pathological pockets ≥ 4 mm. Perisolv® was added initially and directly after the treatment. At all-time points both primary and secondary outcomes were determined for all pockets. In addition, the instrument Oral Health Impact Profile (OHIP) was used as a measurement of quality of life.
Risk assessments was handled by the safety regulation and quality plan of the clinic.The clinic followed the Swedish legalisation, Health and Medical Care Act with quality assurance. If any adverse events during the treatments the local standard operation procedures ensured reporting to concerned authority in Sweden. Participant not fulfilling the study was reported in the patient journal as not completed and statistically noted as missing data.
Regarding the study's safety plan any adverse event during the treatment code list would be decoded and would be covered by the dental insurance.
From the power analysis 32 individuals were minimum to reach a clinically significant difference at 0.5 mm between the groups with alpha 0.05 and power 80%. The IBM SPSS version 27.0 statistical software package (SPSS Inc., Armonk, NY, USA) for personal computer was used in the statistical analyses. Statistics was calculated as means with standard deviation (SD). Independent t-tests (equal variance not assumed) paired t-test and one-way ANOVA test were used to compare inter and intra-group differences. Non-parametric chi-square test was used for categorical variables. Statistical significance was set with 80 percent at p < 0.05. Non visits were recorded as missing data in the statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Test group: non-surgical mechanical treatment and adjunctive treatment Perisolv Control group: non-surgical mechanical treatment
| Arm | Type | Receives |
|---|---|---|
| Non-surgical mechanical treatment with Perisolv® (A) | Experimental | Device: Perisolv (A)The test group will receive the following treatment: In the deepened pockets to be treated, Perisolv is initially applied according to the manufacturers recommendation.Then subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation. In addition an aliquot of Perisolv was left after final debridement. |
| Non-surgical mechanical treatment without Perisolv® (B) | Active comparator | Other: Standard (B)The control group will receive the following treatment: In the deepened pockets to be treated, subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who agree to participate in the study and who also have at least 4 gingival pockets with probing depth ≥5 mm and which at the same time bleed on probing.
- -
Key exclusion criteria (5 listed)
- Individuals with uncontrolled/difficult diabetes mellitus (HbA1c > 7.0)
- Individuals who need antibiotic prophylaxis
- Individuals taking medication with Prednisolone.
- Individuals taking medication that has a known side effect, gingival hyperplasia
- Individuals who took systemic antibiotics 3 months before the start of the study.
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 |
|---|---|---|
| Perisolv (A)Intended for cleaning periodontal pockets for both periodontitis and peri-implantitis. Softens degenerative tissue and biofilm before depuration of periodontal pockets. Does not affect healthy tissue. | Device | Non-surgical mechanical treatment with Perisolv® (A) |
| Standard (B)Deepened periodontal pockets to be treated are performed by subgingivally debridement. This is performed with piezoelectric ultrasound (EMS) under rinsing water and subgingival debridement with hand instrument. | Other | Non-surgical mechanical treatment without Perisolv® (B) |
Primary outcome
probing pocket depth
Time frame: baseline
millimeter
probing pocket depth
Time frame: 3 months
millimeter
probing pocket depth
Time frame: 12 months
millimeter
6 secondary outcomes
bleeding on probing
Time frame: baseline
bleeding on probing
Time frame: 3 months
bleeding on probing
Time frame: 12 months
plaque index
Time frame: baseline
plaque index
Time frame: 3 months
plaque index
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 10 Mar 2023.
- Background: PubMed 26113099Smiley CJ, Tracy SL, Abt E, Michalowicz BS, John MT, Gunsolley J, Cobb CM, Rossmann J, Harrel SK, Forrest JL, Hujoel PP, Noraian KW, Greenwell H, Frantsve-Hawley J, Estrich C, Hanson N. Systematic review and meta-analysis on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015 Jul;146(7):508-24.e5. doi: 10.1016/j.adaj.2015.01.028.
- Background: PubMed 28177120Ferreira MC, Dias-Pereira AC, Branco-de-Almeida LS, Martins CC, Paiva SM. Impact of periodontal disease on quality of life: a systematic review. J Periodontal Res. 2017 Aug;52(4):651-665. doi: 10.1111/jre.12436. Epub 2017 Feb 8.
- Background: PubMed 34517433Citterio F, Gualini G, Chang M, Piccoli GM, Giraudi M, Manavella V, Baima G, Mariani GM, Romano F, Aimetti M. Pocket closure and residual pockets after non-surgical periodontal therapy: A systematic review and meta-analysis. J Clin Periodontol. 2022 Jan;49(1):2-14. doi: 10.1111/jcpe.13547. Epub 2021 Nov 11.
- Background: PubMed 27045432Jepsen K, Jepsen S. Antibiotics/antimicrobials: systemic and local administration in the therapy of mild to moderately advanced periodontitis. Periodontol 2000. 2016 Jun;71(1):82-112. doi: 10.1111/prd.12121.
- Background: PubMed 17146426Guida A. Mechanism of action of sodium hypochlorite and its effects on dentin. Minerva Stomatol. 2006 Sep;55(9):471-82. English, Italian.
- Background: PubMed 29926951Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
- Derived from this study: PubMed 37962876Wallin-Bengtsson V, Scherdin-Almhojd U, Roos-Jansaker AM. Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine - a one-year randomized clinical trial study. Acta Odontol Scand. 2024 Mar 22;83:1-6. doi: 10.1080/00016357.2023.2281486.
- 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.
Ann-Marie AJ Roos Jansaker, Assoc.Prof. principal investigator
Kristianstad University
Questions about this trial
What is this clinical trial studying?
A study testing Perisolv (A) and Standard (B) in people with Periodontitis, run by Kristianstad University.
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 2 inclusion and 5 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 10 Mar 2023. 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?
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?
probing pocket depth (time frame: baseline). The study lists 3 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 NCT05757921, which also lists 7 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 10 Mar 2023.