PeriodontitisNCT06477510
Evaluation of Effect of Non-surgical Periodontal Treatment on Patient's Self Perception of Esthetics
A study testing non-surgical periodontal therapy in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Non-surgical periodontal treatment is a fundamental part of periodontal therapy,including 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to 1 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients in the age group of (18-60 years).
- Presence of ≥ 18 natural teeth
- Ability and willingness to give written informed consent
- Patients belonging to Stage I/II/III periodontitis.
- Systemically healthy individuals.
Who cannot join
- Smokers.
- Patients who have received periodontal treatment within 6 months or taken antibacterial drugs within last 3 months.
- Patient with psychological or systemic disease that can influence the outcome of non-surgical periodontal therapy.
- Presence of tooth loss or caries or prosthesis of any type in anterior teeth.
- Pregnant females or on oral contraceptive pills or hormone replacement therapy.
- Physically and cognitively impaired patients.
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- Teeth with need for endodontic treatment.
- Teeth with Endo-perio lesion.
- Patients with no aesthetic concerns.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effect of Non-surgical Periodontal Treatment on Patient's Self Perception of Esthetics- A Prospective Study
Non-surgical periodontal treatment is a fundamental part of periodontal therapy,including 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. However,despite 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 patient's perception of aesthetics remaining largely unexplored.
Focusing only on physical periodontal measurements, leaves the true impact of periodontitis as well as its treatment on patient's 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 manner.Therefore, the goal of this study (prospective-interventional ) is to to assess the patient's 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.
Read the 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 individual's 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 patient's 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 I/II/III periodontitis and assess the psychometric properties of PAPS in Indian population, assess the ability of Periodontal aesthetic perception scale to detect difference in patient's perception of aesthetics after non-surgical periodontal therapy and correlate self-reported perception of aesthetics with clinical periodontal parameters (CAL,BOP, 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, Rohtak.Translation, 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 I/II/III 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 (urban/rural) 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 patient's 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.
- Conditions
- Periodontitis
- Being tested
- non-surgical periodontal therapy
- Keywords
- aesthetics, patient-reported outomes
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapyProcedure or surgery
Also called scaling and root planing
change in self perception of esthetics and clinical periodontal parameters will be assessed after non-surgical periodontal therapy.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | self perception of esthetics and clinical periodontal parameters will be evaluated in patients with stage I/II/III periodontitis at baseline and post non surgical periodontal therapy. Receives: Procedure: non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale)
Assess Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale) in Indian population
Measured: 12-18 months
Patient's perception of aesthetics by Numeri rating scale
Assess Patient's perception of aesthetics by Numeric rating scale
Measured: 12-18 months
Patient's perception of aesthetics by Global transition scale
Assess Patient's perception of aesthetics by Global transition scale
Measured: 12-18 months
Secondary outcomes (1)
To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display).
To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display) in Indian population
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study population will include consecutive subjects referred to the Department of Periodontics, PGIDS, Rohtak for clinical evaluation. The patients will be screened according to the inclusion and exclusion criteria for eligibility to participate in the study. All participants will be informed about the purpose of the study and only individuals who provide written informed consent prior to the start of the study will be included. After validation of the PAPS scale, patients with Stage I/II/III Periodontitis will be selected, and PAPS score recorded at baseline, then at 4 weeks and 3 month post non-surgical periodontal treatment and clinical parameters recorded at baseline and 3 month post non-surgical periodontal treatment with ultrasonic scaler or hand instruments as required.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Ahmed, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477510
- Sponsor's protocol ID
- Ayeshaperio_12
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Non-surgical Periodontal Treatment on Patient's Self Perception of Esthetics- A Prospective Study
- ClinicalTrials.gov ID
- NCT06477510
- Acronym / sponsor ID
- Ayeshaperio_12
- Conditions
- Periodontitis
- Keywords
- aesthetics, patient-reported outomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jun 2024 (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.
Non-surgical periodontal treatment is a fundamental part of periodontal therapy,including 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. However,despite 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 patient's perception of aesthetics remaining largely unexplored.
Focusing only on physical periodontal measurements, leaves the true impact of periodontitis as well as its treatment on patient's 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 manner.Therefore, the goal of this study (prospective-interventional ) is to to assess the patient's 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 individual's 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 patient's 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 I/II/III periodontitis and assess the psychometric properties of PAPS in Indian population, assess the ability of Periodontal aesthetic perception scale to detect difference in patient's perception of aesthetics after non-surgical periodontal therapy and correlate self-reported perception of aesthetics with clinical periodontal parameters (CAL,BOP, 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, Rohtak.Translation, 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 I/II/III 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 (urban/rural) 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 patient's 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population will include consecutive subjects referred to the Department of Periodontics, PGIDS, Rohtak for clinical evaluation. The patients will be screened according to the inclusion and exclusion criteria for eligibility to participate in the study. All participants will be informed about the purpose of the study and only individuals who provide written informed consent prior to the start of the study will be included. After validation of the PAPS scale, patients with Stage I/II/III Periodontitis will be selected, and PAPS score recorded at baseline, then at 4 weeks and 3 month post non-surgical periodontal treatment and clinical parameters recorded at baseline and 3 month post non-surgical periodontal treatment with ultrasonic scaler or hand instruments as required.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: non-surgical periodontal therapyself perception of esthetics and clinical periodontal parameters will be evaluated in patients with stage I/II/III periodontitis at baseline and post non surgical periodontal therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in the age group of (18-60 years).
- Presence of ≥ 18 natural teeth
- Ability and willingness to give written informed consent
- Patients belonging to Stage I/II/III periodontitis.
- Systemically healthy individuals.
Key exclusion criteria (9 listed)
- Smokers.
- Patients who have received periodontal treatment within 6 months or taken antibacterial drugs within last 3 months.
- Patient with psychological or systemic disease that can influence the outcome of non-surgical periodontal therapy.
- Presence of tooth loss or caries or prosthesis of any type in anterior teeth.
- Pregnant females or on oral contraceptive pills or hormone replacement therapy.
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 |
|---|---|---|
| non-surgical periodontal therapyAlso: scaling and root planingchange in self perception of esthetics and clinical periodontal parameters will be assessed after non-surgical periodontal therapy. | Procedure or surgery | Test group |
Primary outcome
Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale)
Time frame: 12-18 months
Assess Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale) in Indian population
Patient's perception of aesthetics by Numeri rating scale
Time frame: 12-18 months
Assess Patient's perception of aesthetics by Numeric rating scale
Patient's perception of aesthetics by Global transition scale
Time frame: 12-18 months
Assess Patient's perception of aesthetics by Global transition scale
1 secondary outcome
To correlate self-reported perception of esthetics with clinical periodontal parameters (CAL, BOP, PPD, gingival phenotype, gingival recession, interdental papillary height, gingival pigmentation and gingival display).
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Ayesha Ahmed principal investigator
PGIDS, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal therapy in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 9 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 Jun 2024. 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 India. 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?
Contact Dr.Aditi Sangwan (9996002408, aditidalal86@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's perception of aesthetics by PAPS score (Periodontal Aesthetic Perception Scale) (time frame: 12-18 months). The study lists 3 primary outcomes in all. 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 Jun 2024.