PeriodontitisNCT04653714
The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery
A study testing Scaling and root planing and Probiotic lozenges in people with Periodontitis and Obesity, Morbid, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
By World Health Organization (WHO) definition overweight (body mass index (BMI) >24.9) and obesity (BMI >29.9) are defined as abnormal or excessive fat accumulation with many possible impacts on individual's health. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- Scaling and root planing and Probiotic lozenges
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2020to 30 Nov 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years patients undergoing BS (morbidly obese patients (obesity class III) and obese patients (class II and I) with obesity related comorbidities: diabetes mellites type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain, polycystic ovary syndrome) from Department of Abdominal Surgery, University Medical Centre Ljubljana.
- ≥ 16 teeth present
- Diagnoses with periodontitis or gingivitis
- Singed consent
Who cannot join
- Antibiotic and periodontal therapy in previous 6 months
- The need of prophylactic antibiotic therapy
- Pregnant women, lactation
- Cancer and other serious chronic diseases (excluding metabolic syndrome) with known influence on periodontal health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery on the Periodontal and Systemic Inflammation Parameters: a Randomized Double Blinded Controlled Trial
By World Health Organization (WHO) definition overweight (body mass index (BMI) >24.9) and obesity (BMI >29.9) are defined as abnormal or excessive fat accumulation with many possible impacts on individual's health. Association between obesity and associated metabolic syndrome (obesity, hypertension, diabetes mellitus type 2 and dyslipidemia) and oral health has become clear from several studies that proved increased odds of obese patients for developing of caries-related pathologies and periodontal disease. Periodontal disease, a major cause of tooth loss in adults, is an inflammatory disease of periodontal tissue that is initiated by dental plaque bacteria and is modulated by the inflammatory-immune host response factors. Relation between periodontal disease and obesity is bi-directional, through sharing of several proposed local and systemic pathogenesis mechanisms. For treatment of obesity, bariatric surgery (BS) procedures are methods of choice, when other less invasive options fail. They are safe, cost-effective, improve overall health and increase life expectancy. There are several types of BS interventions and most commonly performed BS is laparoscopic sleeve gastrectomy and with second most often, Roux-en-Y gastric bypass. Studies on influence of BS on periodontal health showed diverse results, with some showing no effect, while others demonstrated an increase in the prevalence of periodontitis as well as a further deterioration of periodontal tissues after BS procedure. However, studies on the prevalence of gingivitis, a reversible plaque-induced inflammation of gingiva, and its progression to periodontitis in BS patients is lacking. Furthermore, dental and periodontal status are not routinely evaluated in patients before or after BS. To the best of our knowledge studies on the effect of periodontal therapy before BS are lacking.
Read the detailed description
Obesity is becoming one of the mayor worldwide health problems due to increasing prevalence. In the Slovenia 63.4% of population are overweight (24.99 kg/m² < BMI < 29.99 kg/m²) and 28.6% are obese (BMI > 30 kg/m²). Obese patients have a predisposing factor of many chronic diseases including periodontal disease (PD). PD is an inflammatory disease of tooth supporting tissues that is initiated by dental plaque bacteria and modulated by the inflammatory-immune host response factors. Some of the causes for periodontitis in obese individuals are hyperinflammatory response, different fat metabolism and higher degree of insulin resistance. On the other hand, periodontitis is thought to have a negative effect on some obesity related comorbidities by rising systemic inflammation, increasing insulin resistance, lipid profile and endothelial function.
Several methods have been proposed for weight loss like dieting, physical exercise, pharmacologic treatment and surgical intervention. Bariatric surgery (BS) has been shown to be an effective weight loss strategy and is proposed as a frontline therapy for adult patients with severe obesity. The outcomes of bariatric surgery show decreased levels of pro-inflammatory markers such as Tumour Necrosis Factor alpha (TNF-α), interleukine-6 (IL6) and C-reactive protein (CRP) and therefore improvement of general inflammation status. Research papers observing association between BS and PD mostly advocate worsening of periodontal status and oral health as a complication of BS. Observational studies have shown that obese patients undergoing BS procedures have a high prevalence of periodontal disease and even though metabolic parameters are advancing to normal values after BS, inflammatory response to plaque bacteria in the gingiva is increased, with possible additional destruction of periodontal tissues. The reasons for high prevalence as well as deterioration after BS procedure is not completely understood. To the best of our knowledge, there are no interventional studies with non-surgical periodontal therapy that aim to lower PD progression after BS.
The aim is to investigate the influence of non-surgical periodontal therapy 1 month before BS in patients diagnosed with periodontitis and gingivitis on the level of reduction in local/systemic inflammatory and periodontal parameters. The second aim is to test whether implemented periodontal therapy has some impact on metabolic parameters and comorbidities of obesity after BS.
Participants will be selected in a randomized, interventional, blinded (examiner), prospective study, from 70 obese patients indicated for BS with criteria obesity class III (ITM over 40 kg/m2) and class I and II with obesity if related disease are present: diabetes mellitus type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain, polycystic ovary syndrome. Patients will be recruited from Department of Abdominal Surgery, University Medical Centre Ljubljana, were BS procedure will be performed, and pre- and post-operative systemic and obesity related data will be collected. All relevant medical data will be taken from the records.
All the oral health intervention will be held at the Department for Oral Diseases and Periodontology, Dental Clinic, University Medical Centre Ljubljana. At the first visit general health, socioeconomic, dental information will be recorded by a questionnaire before surgical procedure. At the same time patients will undergo periodontal examination (number of the teeth, prosthetic rehabilitation status, full mouth plaque score (FMPS), full mouth bleeding score (FMBS), periodontal pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), recession, furcation involvement, teeth mobility.
After oral examination, two study groups will be established (gingivitis n=30; and periodontitis patients n=40).
One month before scheduled BS periodontal therapy will be performed in all patients regarding their periodontal diagnosis (e.g. periodontitis or gingivitis) and previously predetermined randomisation to (test and control group) All included patients will be properly instructed and motivated for oral hygiene and fill out OHIP-14 questionnaire.
Patients with gingivitis in the test group (n=15) will be treated with supragingival debridement and with probiotic lozenges with strains of Lactobacillus brevis and Lactobacillus plantarum once a day for 3 months and in the control group (n=15) by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges.
Patients with periodontitis in the test group (n=20) will be treated by conventional non-surgical root debridement and in the control group (n=20), as a placebo treatment, by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only.
- Conditions
- Periodontitis, Obesity, Morbid, Bariatric Surgery Candidate
- Being tested
- Scaling and root planing, Probiotic lozenges
- Medical subject headings
- Periodontitis, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Patients with periodontitis in the test group will be treated by conventional non-surgical root debridement and in the control group by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only.
Probiotic lozengesDevice
Patients with gingivitis in the test group will be treated with supragingival debridement and with probiotic lozenges with strains of Lactobacillus brevis and Lactobacillus plantarum once a day for 3 months and in the control group by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges.
| Study group | Role | What they receive |
|---|---|---|
| Full mouth debridement | Experimental | Supragingival plaque/calculus removal and scaling and root planing Receives: Procedure: Scaling and root planing |
| Supragingival plaque/calculus removal | Sham comparator | Supragingival plaque and calculus removal Receives: Procedure: Scaling and root planing |
| Probiotic lozenges | Experimental | Daily usage of probiotic lozenges Receives: Device: Probiotic lozenges |
| Placebo lozenges | Active comparator | Daily usage of placebo lozenges Receives: Device: Probiotic lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Bleeding on Probing (BOP) Sites
Percentage of probing sites that bleed will be calcuated from fill mouth record
Measured: at 7 months after treatment
Secondary outcomes (3)
Probing Pocket Depth (PPD) change
Difference between the baseline and 7 months post-treatment PPD
Measured: at 7 months post treatment
Clinical Attachment Level (CAL) change
Difference between the baseline and 7 months post-treatment CAL
Measured: at 7 months post treatment
C-reactive protein (CRP)
CRP levels in the blood increase when there is a condition causing inflammation somewhere in the body.
Measured: at 7 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jun 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653714
- Sponsor's protocol ID
- ULjubljana
- Status last verified
- Dec 2021
- First submitted
- 23 Oct 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colak D, Cmok Kucic A, Pintar T, Gaspirc B, Gaspersic R. Periodontal and systemic health of morbidly obese patients eligible for bariatric surgery: a cross-sectional study. BMC Oral Health. 2022 May 13;22(1):174. doi: 10.1186/s12903-022-02207-0.
PubMed 35562737
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery on the Periodontal and Systemic Inflammation Parameters: a Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT04653714
- Acronym / sponsor ID
- ULjubljana
- Conditions
- Periodontitis, Obesity, Morbid, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Dec 2020 (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.
By World Health Organization (WHO) definition overweight (body mass index (BMI) >24.9) and obesity (BMI >29.9) are defined as abnormal or excessive fat accumulation with many possible impacts on individual's health. Association between obesity and associated metabolic syndrome (obesity, hypertension, diabetes mellitus type 2 and dyslipidemia) and oral health has become clear from several studies that proved increased odds of obese patients for developing of caries-related pathologies and periodontal disease. Periodontal disease, a major cause of tooth loss in adults, is an inflammatory disease of periodontal tissue that is initiated by dental plaque bacteria and is modulated by the inflammatory-immune host response factors. Relation between periodontal disease and obesity is bi-directional, through sharing of several proposed local and systemic pathogenesis mechanisms. For treatment of obesity, bariatric surgery (BS) procedures are methods of choice, when other less invasive options fail. They are safe, cost-effective, improve overall health and increase life expectancy. There are several types of BS interventions and most commonly performed BS is laparoscopic sleeve gastrectomy and with second most often, Roux-en-Y gastric bypass. Studies on influence of BS on periodontal health showed diverse results, with some showing no effect, while others demonstrated an increase in the prevalence of periodontitis as well as a further deterioration of periodontal tissues after BS procedure. However, studies on the prevalence of gingivitis, a reversible plaque-induced inflammation of gingiva, and its progression to periodontitis in BS patients is lacking. Furthermore, dental and periodontal status are not routinely evaluated in patients before or after BS. To the best of our knowledge studies on the effect of periodontal therapy before BS are lacking.
Detailed description
Obesity is becoming one of the mayor worldwide health problems due to increasing prevalence. In the Slovenia 63.4% of population are overweight (24.99 kg/m² < BMI < 29.99 kg/m²) and 28.6% are obese (BMI > 30 kg/m²). Obese patients have a predisposing factor of many chronic diseases including periodontal disease (PD). PD is an inflammatory disease of tooth supporting tissues that is initiated by dental plaque bacteria and modulated by the inflammatory-immune host response factors. Some of the causes for periodontitis in obese individuals are hyperinflammatory response, different fat metabolism and higher degree of insulin resistance. On the other hand, periodontitis is thought to have a negative effect on some obesity related comorbidities by rising systemic inflammation, increasing insulin resistance, lipid profile and endothelial function.
Several methods have been proposed for weight loss like dieting, physical exercise, pharmacologic treatment and surgical intervention. Bariatric surgery (BS) has been shown to be an effective weight loss strategy and is proposed as a frontline therapy for adult patients with severe obesity. The outcomes of bariatric surgery show decreased levels of pro-inflammatory markers such as Tumour Necrosis Factor alpha (TNF-α), interleukine-6 (IL6) and C-reactive protein (CRP) and therefore improvement of general inflammation status. Research papers observing association between BS and PD mostly advocate worsening of periodontal status and oral health as a complication of BS. Observational studies have shown that obese patients undergoing BS procedures have a high prevalence of periodontal disease and even though metabolic parameters are advancing to normal values after BS, inflammatory response to plaque bacteria in the gingiva is increased, with possible additional destruction of periodontal tissues. The reasons for high prevalence as well as deterioration after BS procedure is not completely understood. To the best of our knowledge, there are no interventional studies with non-surgical periodontal therapy that aim to lower PD progression after BS.
The aim is to investigate the influence of non-surgical periodontal therapy 1 month before BS in patients diagnosed with periodontitis and gingivitis on the level of reduction in local/systemic inflammatory and periodontal parameters. The second aim is to test whether implemented periodontal therapy has some impact on metabolic parameters and comorbidities of obesity after BS.
Participants will be selected in a randomized, interventional, blinded (examiner), prospective study, from 70 obese patients indicated for BS with criteria obesity class III (ITM over 40 kg/m2) and class I and II with obesity if related disease are present: diabetes mellitus type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain, polycystic ovary syndrome. Patients will be recruited from Department of Abdominal Surgery, University Medical Centre Ljubljana, were BS procedure will be performed, and pre- and post-operative systemic and obesity related data will be collected. All relevant medical data will be taken from the records.
All the oral health intervention will be held at the Department for Oral Diseases and Periodontology, Dental Clinic, University Medical Centre Ljubljana. At the first visit general health, socioeconomic, dental information will be recorded by a questionnaire before surgical procedure. At the same time patients will undergo periodontal examination (number of the teeth, prosthetic rehabilitation status, full mouth plaque score (FMPS), full mouth bleeding score (FMBS), periodontal pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), recession, furcation involvement, teeth mobility.
After oral examination, two study groups will be established (gingivitis n=30; and periodontitis patients n=40).
One month before scheduled BS periodontal therapy will be performed in all patients regarding their periodontal diagnosis (e.g. periodontitis or gingivitis) and previously predetermined randomisation to (test and control group) All included patients will be properly instructed and motivated for oral hygiene and fill out OHIP-14 questionnaire.
Patients with gingivitis in the test group (n=15) will be treated with supragingival debridement and with probiotic lozenges with strains of Lactobacillus brevis and Lactobacillus plantarum once a day for 3 months and in the control group (n=15) by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges.
Patients with periodontitis in the test group (n=20) will be treated by conventional non-surgical root debridement and in the control group (n=20), as a placebo treatment, by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full mouth debridement | Experimental | Procedure: Scaling and root planingSupragingival plaque/calculus removal and scaling and root planing |
| Supragingival plaque/calculus removal | Sham comparator | Procedure: Scaling and root planingSupragingival plaque and calculus removal |
| Probiotic lozenges | Experimental | Device: Probiotic lozengesDaily usage of probiotic lozenges |
| Placebo lozenges | Active comparator | Device: Probiotic lozengesDaily usage of placebo lozenges |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years patients undergoing BS (morbidly obese patients (obesity class III) and obese patients (class II and I) with obesity related comorbidities: diabetes mellites type II, Hypertension, hyperlipidaemia, obstructive sleep apnea, articular pain, polycystic ovary syndrome) from Department of Abdominal Surgery, University Medical Centre Ljubljana.
- ≥ 16 teeth present
- Diagnoses with periodontitis or gingivitis
- Singed consent
Key exclusion criteria (4 listed)
- Antibiotic and periodontal therapy in previous 6 months
- The need of prophylactic antibiotic therapy
- Pregnant women, lactation
- Cancer and other serious chronic diseases (excluding metabolic syndrome) with known influence on periodontal health
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 |
|---|---|---|
| Scaling and root planingPatients with periodontitis in the test group will be treated by conventional non-surgical root debridement and in the control group by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only. | Procedure or surgery | Full mouth debridement, Supragingival plaque/calculus removal |
| Probiotic lozengesPatients with gingivitis in the test group will be treated with supragingival debridement and with probiotic lozenges with strains of Lactobacillus brevis and Lactobacillus plantarum once a day for 3 months and in the control group by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges. | Device | Placebo lozenges, Probiotic lozenges |
Primary outcome
Percentage of Bleeding on Probing (BOP) Sites
Time frame: at 7 months after treatment
Percentage of probing sites that bleed will be calcuated from fill mouth record
3 secondary outcomes
Probing Pocket Depth (PPD) change
Time frame: at 7 months post treatment
Clinical Attachment Level (CAL) change
Time frame: at 7 months post treatment
C-reactive protein (CRP)
Time frame: at 7 months post treatment
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 17 Dec 2021.
- Derived from this study: PubMed 35562737Colak D, Cmok Kucic A, Pintar T, Gaspirc B, Gaspersic R. Periodontal and systemic health of morbidly obese patients eligible for bariatric surgery: a cross-sectional study. BMC Oral Health. 2022 May 13;22(1):174. doi: 10.1186/s12903-022-02207-0.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing and Probiotic lozenges in people with Periodontitis and Obesity, Morbid, run by University of Ljubljana at 1 site in Slovenia.
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 4 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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. Some participants in this study may receive a placebo. 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?
Percentage of Bleeding on Probing (BOP) Sites (time frame: at 7 months after treatment). 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 NCT04653714, which also lists 1 linked publication.
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 17 Dec 2021.