Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477510
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-23
Brief Title:
Evaluation of Effect of Non-surgical Periodontal Treatment on Patients Self Perception of Esthetics
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
Official Title:
Evaluation of Effect of Non-surgical Periodontal Treatment on Patients Self Perception of Esthetics- A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-surgical periodontal treatment is a fundamental part of periodontal therapyincluding supportive therapy It has been proven to be efficacious in reducing inflammation probing pocket depth and number of diseased sites in patients affected by periodontitis often limiting the need for additional treatment approaches Howeverdespite being such a widely administered treatment the effect of non-surgical periodontal treatment on patient reported outcomes has remained restricted to parameters such as pain and sensitivity only with patients perception of aesthetics remaining largely unexplored
Focusing only on physical periodontal measurements leaves the true impact of periodontitis as well as its treatment on patients well-being largely under recognized With the development of the periodontal aesthetics perception scale PAPS it is possible to assess the results in a standardized mannerTherefore the goal of this study prospective-interventional is to to assess the patients self-perception of aesthetics using a standardized tool after non surgical periodontal treatment and how much of changes in aesthetics are perceived by the patient This would be helpful in understanding and managing patient expectations Also utilizing a standardized tool would reduce heterogeneity bias by providing comparable data between studies for future research on understanding patient preferences
Focusing only on physical periodontal measurements leaves the true impact of periodontitis as well as its treatment on patients well-being largely under recognized With the development of the periodontal aesthetics perception scale PAPS it is possible to assess the results in a standardized mannerTherefore the goal of this study prospective-interventional is to to assess the patients self-perception of aesthetics using a standardized tool after non surgical periodontal treatment and how much of changes in aesthetics are perceived by the patient This would be helpful in understanding and managing patient expectations Also utilizing a standardized tool would reduce heterogeneity bias by providing comparable data between studies for future research on understanding patient preferences
Detailed Description:
Periodontal disease refers to inflammation of the periodontal tissues resulting in clinical attachment loss alveolar bone loss and periodontal pocket formation Periodontal disease is amongst one of the most common diseases affecting majority of the population around the world Patients with periodontal diseases may present with bleeding redness swelling or edema in the gingiva gingival recession gingival enlargement loss of the supporting periodontal tissues and tooth mobility All these conditions affecting the periodontium are detrimental for individuals quality of life and may also disrupt their esthetic appearance A number of factors are substantial for dental esthetics such as color and shape of the teeth and shape of the dental arch However gingival health and appearance is also crucial for an esthetically pleasant smile and patients with periodontal problems may face aesthetic problems Gingival recessions in the anterior teeth can often be a topic of concern and this non-aesthetic appearance can be observed within the patients smile speech or chewing Localized or generalized gingival enlargement may also result in both aesthetic and functional problems for affected patients Additionally the color of gingiva as well excess gingival display can pose esthetic concerns
Until recently clinical research has been focused mainly on the course of periodontal disease its diagnosis development of appropriate treatments as well as its clinical response In this context a real full impact study which refers to perceptions and satisfaction of patients in relation to the treatment has historically not been an object of interest in most investigations However in recent years patients own assessments of dentofacial aesthetics have become an increasingly popular topic gradually emphasizing on esthetic conditions as perceived by patients
Therefore the present study has been designed to evaluate the change in patients perception of aesthetics post non-surgical periodontal treatment using the PAPS scale the Numeric rating scale and global rating scale with the aim to explore the effect of non-surgical periodontal treatment in stage IIIIII periodontitis and assess the psychometric properties of PAPS in Indian population assess the ability of Periodontal aesthetic perception scale to detect difference in patients perception of aesthetics after non-surgical periodontal therapy and correlate self-reported perception of aesthetics with clinical periodontal parameters CALBOP PPD gingival phenotype gingival recession interdental papillary height gingival pigmentation and gingival display
The present longitudinal study will be conducted in the Department of Periodontics Post Graduate Institute of Dental Sciences RohtakTranslation adaptation and validation of PAPS Periodontal aesthetic perception scale will be done in Indian population by using the questionnaire on patients reporting to department of Periodontics PGIDS Rohtak Following this systemically healthy patients with Stage IIIIII Periodontitis will be recruited on basis of inclusion and exclusion criteria For each participant demographic data like age sex level of education marital status socio-economic status and area of residence urbanrural will be recorded Assessment of self-perception aesthetics using PAPS score NRS and Global Transition Scale will be done at baseline For all patients periodontal charting will be done from second premolar to second premolar in both maxillary and mandibular arch
Oral hygiene instructions and mechanical supragingival scaling followed by subgingival instrumentation as needed on case-to-case basis with both ultrasonic scalers as well as hand instruments No adjunctive chemical oral hygiene aids or antibiotics will be used
Re- evaluation of patients perception of esthetics will be done at 4 weeks Both patients perception of esthetics and clinical periodontal parameters clinical attachment level CAL probing pocket depth PPD bleeding on probing BOP plaque index PI gingival phenotype gingival recession interdental papillary height gingival pigmentation and gingival display will be re-evaluated at 3 month follow up appointment post non surgical periodontal treatment with ultrasonic scaler or hand instruments as required
Until recently clinical research has been focused mainly on the course of periodontal disease its diagnosis development of appropriate treatments as well as its clinical response In this context a real full impact study which refers to perceptions and satisfaction of patients in relation to the treatment has historically not been an object of interest in most investigations However in recent years patients own assessments of dentofacial aesthetics have become an increasingly popular topic gradually emphasizing on esthetic conditions as perceived by patients
Therefore the present study has been designed to evaluate the change in patients perception of aesthetics post non-surgical periodontal treatment using the PAPS scale the Numeric rating scale and global rating scale with the aim to explore the effect of non-surgical periodontal treatment in stage IIIIII periodontitis and assess the psychometric properties of PAPS in Indian population assess the ability of Periodontal aesthetic perception scale to detect difference in patients perception of aesthetics after non-surgical periodontal therapy and correlate self-reported perception of aesthetics with clinical periodontal parameters CALBOP PPD gingival phenotype gingival recession interdental papillary height gingival pigmentation and gingival display
The present longitudinal study will be conducted in the Department of Periodontics Post Graduate Institute of Dental Sciences RohtakTranslation adaptation and validation of PAPS Periodontal aesthetic perception scale will be done in Indian population by using the questionnaire on patients reporting to department of Periodontics PGIDS Rohtak Following this systemically healthy patients with Stage IIIIII Periodontitis will be recruited on basis of inclusion and exclusion criteria For each participant demographic data like age sex level of education marital status socio-economic status and area of residence urbanrural will be recorded Assessment of self-perception aesthetics using PAPS score NRS and Global Transition Scale will be done at baseline For all patients periodontal charting will be done from second premolar to second premolar in both maxillary and mandibular arch
Oral hygiene instructions and mechanical supragingival scaling followed by subgingival instrumentation as needed on case-to-case basis with both ultrasonic scalers as well as hand instruments No adjunctive chemical oral hygiene aids or antibiotics will be used
Re- evaluation of patients perception of esthetics will be done at 4 weeks Both patients perception of esthetics and clinical periodontal parameters clinical attachment level CAL probing pocket depth PPD bleeding on probing BOP plaque index PI gingival phenotype gingival recession interdental papillary height gingival pigmentation and gingival display will be re-evaluated at 3 month follow up appointment post non surgical periodontal treatment with ultrasonic scaler or hand instruments as required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None