Periodontal DiseasesNCT04938089
Effect of Periodontal Maintenance Therapy on Tooth Loss in Regular and Irregular Compliant Smokers and Non-Smokers: A Cohort Retrospective Analysis With a Follow-up Up to 40 Years
An observational study of Periodontal Diseases and Tooth Loss, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Periodontal diseases are infections cause by dental plaque (Socransky, 1970). Risk factors are present which modify the course of disease progression. One of these risk factors is tobacco smoking, which was first evaluated by Pindborg in 1947 and later by Grossi et al. in 1995. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Tooth Loss, Compliance
- What is being tested?
- Maintenance
- How many people
- 160 participants
- Where
- 1 siteLebanon
- Study dates
- May 2022to Jul 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The location and recruitment of patients was conducted from a specialized private dental clinic in periodontology.
Who may be able to join
- Age > 18 years.
- Smoker patients (> 9 cigarettes per day).
- At least 10 years of continued periodontal maintenance therapy.
- Diagnosis of generalized chronic periodontitis or gingivitis.
- Patient had undergone active periodontal therapy comprised of non-surgical and/or surgical therapy.
Who cannot join
- Patients with bisphosphonate therapy.
- Patients with chemo or radiotherapy.
- Patients with hormonal therapy.
- Patients with a history of refractory periodontitis or repeated abscess formation.
- Patients with debilitating diseases that could impair the immune system (HIV/AIDS, cancer, or autoimmune diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Periodontal diseases are infections cause by dental plaque (Socransky, 1970). Risk factors are present which modify the course of disease progression. One of these risk factors is tobacco smoking, which was first evaluated by Pindborg in 1947 and later by Grossi et al. in 1995. They found that tobacco smoking was strongly associated with attachment loss, bone loss, and lastly, tooth loss. Tooth loss in one of the most visible results of periodontal disease, which negatively affects physiological and psychological patient's life. The effects of cigarette smoking on periodontal status are independent of the plaque index and oral hygiene of the patient, due to the direct influence of tobacco on periodontal tissues.
Several studies have demonstrated the effectiveness of periodontal therapy in reducing the rate of tooth loss as well as the importance of patient compliance with periodontal maintenance therapy and adequate oral hygiene practice in achieving this reduction. Compliance is the main problem faced in periodontal maintenance therapy. Low rates of compliance and patient adherence to a maintenance program was reported in the literature. Periodontal maintenance therapy can be considered a critical factor for success in controlling periodontitis and in the long-term maintenance of teeth. In addition, neglecting a regular periodontal maintenance therapy program has been associated with increased risk of reinfection and progression of periodontitis, as well as increased tooth loss. The establishment of a criteria for time interval between different supportive periodontal maintenance visits, is still controversial.
Read more
Smokers are associated with low level of compliance to prevent being constantly reminded of quitting smoking as well as the health complications associated with the habit. There is a void in the literature addressing the direct influence of compliance and adherence in periodontal maintenance therapy and its contribution to arrest periodontitis progression, minimizing tooth loss, specifically in tobacco smoking patients, whether they are regular or irregular compliant with a long term follow-up up to 40 years. On the other hand, there is moderate scientific evidence that the independent effect of smoking is associated with the occurrence of tooth loss in individuals undergoing periodontal maintenance therapy. Lastly, only very few studies reported the specific outcome of periodontal maintenance therapy on tooth loss in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers.
The focused question in this study is "Does periodontal maintenance therapy affect annual tooth loss rates differently in regular and irregular compliant smokers and non-smokers?".
Read the detailed description
Moderate scientific evidence that the independent effect of smoking is associated with the occurrence of tooth loss in individuals undergoing periodontal maintenance therapy. Only very few studies specifically reported the outcome of tooth loss and periodontal maintenance program in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers.
The researcher will analyze the data provided by a specialized dental clinic in the field of periodontology and will divide the subjects into four groups: Group ICS (irregular compliant smoker), Group RCS (regular compliant smoker), Group ICN (irregular compliant non-smoker), and lastly, Group RCN (regular compliant non-smoker). The subjects present in the data will be randomly selected and divided into the appropriate groups with the aid of a permutation table. The researcher will not call the patient and perform a clinical examination but rather analyze the data retrospectively. Statistical data will be compared according to annual tooth loss rates and OR of tooth loss will be calculated for each group. After statistical analysis, the researcher will formulate proper concluding remarks regarding the importance of periodontal maintenance therapy on tooth loss rates in regular and irregular compliant smokers and non-smokers.
Primary objective:
Determine whether periodontal maintenance therapy decreases tooth loss in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers after 40 years of follow-up.
Secondary objective:
Shed light on the importance of periodontal maintenance therapy, in its ability to reduce tooth loss, in smokers and non-smokers after 40 years of follow-up.
- Conditions
- Periodontal Diseases, Tooth Loss, Compliance, Smoking
- Being tested
- Maintenance
- Keywords
- Compliance, Maintenance, Non-Smokers, Smokers, Tobacco, Tooth Loss
- Medical subject headings
- Periodontal Diseases, Tooth Loss, Patient Compliance, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaintenanceOther
Regular compliant individual is defined in the study as a subject attending 100% of his/her recall visits with a maximum interval of 6 months. Irregular compliant individual is defined as a subject who missed at least one of the recall visits but continued to appear on an irregular basis with a maximum interval of 18 months, non-smoker individual is defined as a subject who never smoked, and lastly, smoker individual is defined as a subject who is smoking > 9 cigarettes per day.
| Study group | Role | What they receive |
|---|---|---|
| ICS | Irregular compliant smoker Receives: Other: Maintenance | |
| RCS | Regular compliant smoker Receives: Other: Maintenance | |
| ICN | Irregular compliant non-smoker Receives: Other: Maintenance | |
| RCN | Regular compliant non-smoker Receives: Other: Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Loss
Determine whether periodontal maintenance therapy affects tooth loss rates in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers after 40 years of follow-up.
Measured: Up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study startMay 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roudy Khayat, Saint-Joseph University
- Investigators
- Nadim Mokbel, Pr, Study director, Saint-Joseph UniversityRoudy Khayat, Dr, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938089
- Sponsor's protocol ID
- USJ-2021-35
- Status last verified
- Apr 2022
- First submitted
- 16 Jun 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontal Maintenance Therapy on Tooth Loss in Regular and Irregular Compliant Smokers and Non-Smokers: A Cohort Retrospective Analysis With a Follow-up Up to 40 Years
- ClinicalTrials.gov ID
- NCT04938089
- Acronym / sponsor ID
- USJ-2021-35
- Conditions
- Periodontal Diseases, Tooth Loss, Compliance, Smoking
- Keywords
- Compliance, Maintenance, Non-Smokers, Smokers, Tobacco, Tooth Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 24 Jun 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.
Periodontal diseases are infections cause by dental plaque (Socransky, 1970). Risk factors are present which modify the course of disease progression. One of these risk factors is tobacco smoking, which was first evaluated by Pindborg in 1947 and later by Grossi et al. in 1995. They found that tobacco smoking was strongly associated with attachment loss, bone loss, and lastly, tooth loss. Tooth loss in one of the most visible results of periodontal disease, which negatively affects physiological and psychological patient's life. The effects of cigarette smoking on periodontal status are independent of the plaque index and oral hygiene of the patient, due to the direct influence of tobacco on periodontal tissues.
Several studies have demonstrated the effectiveness of periodontal therapy in reducing the rate of tooth loss as well as the importance of patient compliance with periodontal maintenance therapy and adequate oral hygiene practice in achieving this reduction. Compliance is the main problem faced in periodontal maintenance therapy. Low rates of compliance and patient adherence to a maintenance program was reported in the literature. Periodontal maintenance therapy can be considered a critical factor for success in controlling periodontitis and in the long-term maintenance of teeth. In addition, neglecting a regular periodontal maintenance therapy program has been associated with increased risk of reinfection and progression of periodontitis, as well as increased tooth loss. The establishment of a criteria for time interval between different supportive periodontal maintenance visits, is still controversial.
Smokers are associated with low level of compliance to prevent being constantly reminded of quitting smoking as well as the health complications associated with the habit. There is a void in the literature addressing the direct influence of compliance and adherence in periodontal maintenance therapy and its contribution to arrest periodontitis progression, minimizing tooth loss, specifically in tobacco smoking patients, whether they are regular or irregular compliant with a long term follow-up up to 40 years. On the other hand, there is moderate scientific evidence that the independent effect of smoking is associated with the occurrence of tooth loss in individuals undergoing periodontal maintenance therapy. Lastly, only very few studies reported the specific outcome of periodontal maintenance therapy on tooth loss in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers.
The focused question in this study is "Does periodontal maintenance therapy affect annual tooth loss rates differently in regular and irregular compliant smokers and non-smokers?".
Detailed description
Moderate scientific evidence that the independent effect of smoking is associated with the occurrence of tooth loss in individuals undergoing periodontal maintenance therapy. Only very few studies specifically reported the outcome of tooth loss and periodontal maintenance program in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers.
The researcher will analyze the data provided by a specialized dental clinic in the field of periodontology and will divide the subjects into four groups: Group ICS (irregular compliant smoker), Group RCS (regular compliant smoker), Group ICN (irregular compliant non-smoker), and lastly, Group RCN (regular compliant non-smoker). The subjects present in the data will be randomly selected and divided into the appropriate groups with the aid of a permutation table. The researcher will not call the patient and perform a clinical examination but rather analyze the data retrospectively. Statistical data will be compared according to annual tooth loss rates and OR of tooth loss will be calculated for each group. After statistical analysis, the researcher will formulate proper concluding remarks regarding the importance of periodontal maintenance therapy on tooth loss rates in regular and irregular compliant smokers and non-smokers.
Primary objective:
Determine whether periodontal maintenance therapy decreases tooth loss in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers after 40 years of follow-up.
Secondary objective:
Shed light on the importance of periodontal maintenance therapy, in its ability to reduce tooth loss, in smokers and non-smokers after 40 years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICS | – | Other: MaintenanceIrregular compliant smoker |
| RCS | – | Other: MaintenanceRegular compliant smoker |
| ICN | – | Other: MaintenanceIrregular compliant non-smoker |
| RCN | – | Other: MaintenanceRegular compliant non-smoker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The location and recruitment of patients was conducted from a specialized private dental clinic in periodontology.
Key inclusion criteria (5 listed)
- Age > 18 years.
- Smoker patients (> 9 cigarettes per day).
- At least 10 years of continued periodontal maintenance therapy.
- Diagnosis of generalized chronic periodontitis or gingivitis.
- Patient had undergone active periodontal therapy comprised of non-surgical and/or surgical therapy.
Key exclusion criteria (5 listed)
- Patients with bisphosphonate therapy.
- Patients with chemo or radiotherapy.
- Patients with hormonal therapy.
- Patients with a history of refractory periodontitis or repeated abscess formation.
- Patients with debilitating diseases that could impair the immune system (HIV/AIDS, cancer, or autoimmune diseases).
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 |
|---|---|---|
| MaintenanceRegular compliant individual is defined in the study as a subject attending 100% of his/her recall visits with a maximum interval of 6 months. Irregular compliant individual is defined as a subject who missed at least one of the recall visits but continued to appear on an irregular basis with a maximum interval of 18 months, non-smoker individual is defined as a subject who never smoked, and lastly, smoker individual is defined as a subject who is smoking > 9 cigarettes per day. | Other | ICN, ICS, RCN, RCS |
Primary outcome
Tooth Loss
Time frame: Up to 40 years
Determine whether periodontal maintenance therapy affects tooth loss rates in regular and irregular compliant smokers compared to regular and irregular compliant non-smokers after 40 years of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Nadim Mokbel, Pr study director
Saint-Joseph University
Roudy Khayat, Dr principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Tooth Loss, run by Saint-Joseph University at 1 site in Lebanon.
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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Lebanon. 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?
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?
Tooth Loss (time frame: Up to 40 years). 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 27 Apr 2022.