Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT04938089 |
Other study ID # |
USJ-2021-35 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 2022 |
Est. completion date |
July 2022 |
Study information
Verified date |
April 2022 |
Source |
Saint-Joseph University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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?".
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.