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

NCT04938089 | Unknown

• 1 other identifier: USJ-2021-35
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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?".

Conditions

Periodontal Diseases; Tooth Loss; Compliance; Smoking

Keywords

Compliance; Maintenance; Non-Smokers; Smokers; Tobacco; Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 40 years

Study Arms (4)

ICS

Irregular compliant smoker

Other: Maintenance

RCS

Regular compliant smoker

Other: Maintenance

ICN

Irregular compliant non-smoker

Other: Maintenance

RCN

Regular compliant non-smoker

Other: Maintenance

Interventions

Maintenance OTHER

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.

ICN; ICS; RCN; RCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The location and recruitment of patients was conducted from a specialized private dental clinic in periodontology.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Periodontal Diseases; Tooth Loss; Patient Compliance; Smoking

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Nadim Mokbel, Pr

  Saint-Joseph University

  STUDY DIRECTOR

• Roudy Khayat, Dr

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: May 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

LE (1)