PeriodontitisNCT05449938
Periodontal Phenotype and Scaling and Root Planing
A study testing Scaling and root planing in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Periodontal phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. Taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to… Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2021to Aug 2022
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.
Who cannot join
- Systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders.
- Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years.
- Current or former smoker or use of tobacco in any form
- History of periodontal treatment in last 2 years
- Crowding in anterior teeth.
- Pregnant or lactating females.
- Individuals with restorations on anterior teeth.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute Of Dental Science
Rohtak, Haryana, 124001
Sanjay Tewari, MDS, 01262283876, principalpgids@yahoo.in
Ambika Gupta, MDS
About this study
Official title: Clinical Evaluation of Impact of Periodontal Phenotype on the Outcome of Scaling and Root Planing in Patients With Periodontitis: A Comparative Interventional Study
Periodontal phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. Taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to periodontal phenotype.
With this aim, the present study would be conducted to assess the influence of periodontal phenotype on outcome of scaling and root planing in periodontitis patients.
Read the detailed description
AIM: To evaluate the influence of periodontal phenotype on the outcomes of scaling and root planing in periodontitis patients.
OBJECTIVES:
To assess the improvement in pocket probing depth (PPD), clinical attachment level (CAL), bleeding in pocket probing (BOPP), bleeding on marginal probing (BOMP), gingival marginal position (GMP), gingival recession (GR), plaque index (PI), and gingival index (GI) after scaling and root planing (SRP) in periodontitis patients with thin or thick periodontal phenotype.
SETTING: Department of periodontics and oral implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Comparative Interventional study.
TIME FRAME: 12 months (september 2021- August 2022)
POPULATION:
Systemically healthy patients with periodontitis (periodontitis stage II and stage III) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Scaling and root planing involves removal of plaque and calculus on tooth surface.
| Study group | Role | What they receive |
|---|---|---|
| Thick periodontal phenotype | Experimental | Stage II and stage III periodontitis Patient with thick periodontal phenotype will be enrolled using probe transparency method . Receives: Procedure: Scaling and root planing |
| Thin periodontal phenotype | Active comparator | Stage II and stage III periodontitis Patient with thin periodontal phenotype will be enrolled using probe transparency method. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Change in pocket probing depth from baseline to 6 months
Measured: 6 months
BLEEDING ON POCKET PROBING (BOPP)
Change in bleeding on pocket probing depth from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Sep 2021
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krishan Kant, BDS, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449938
- Sponsor's protocol ID
- Krishan kant perio
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2022
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Impact of Periodontal Phenotype on the Outcome of Scaling and Root Planing in Patients With Periodontitis: A Comparative Interventional Study
- ClinicalTrials.gov ID
- NCT05449938
- Acronym / sponsor ID
- Krishan kant perio
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 8 Jul 2022 (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 phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. Taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to periodontal phenotype.
With this aim, the present study would be conducted to assess the influence of periodontal phenotype on outcome of scaling and root planing in periodontitis patients.
Detailed description
AIM: To evaluate the influence of periodontal phenotype on the outcomes of scaling and root planing in periodontitis patients.
OBJECTIVES:
To assess the improvement in pocket probing depth (PPD), clinical attachment level (CAL), bleeding in pocket probing (BOPP), bleeding on marginal probing (BOMP), gingival marginal position (GMP), gingival recession (GR), plaque index (PI), and gingival index (GI) after scaling and root planing (SRP) in periodontitis patients with thin or thick periodontal phenotype.
SETTING: Department of periodontics and oral implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Comparative Interventional study.
TIME FRAME: 12 months (september 2021- August 2022)
POPULATION:
Systemically healthy patients with periodontitis (periodontitis stage II and stage III) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thick periodontal phenotype | Experimental | Procedure: Scaling and root planingStage II and stage III periodontitis Patient with thick periodontal phenotype will be enrolled using probe transparency method . |
| Thin periodontal phenotype | Active comparator | Procedure: Scaling and root planingStage II and stage III periodontitis Patient with thin periodontal phenotype will be enrolled using probe transparency method. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.
Key exclusion criteria (7 listed)
- Systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders.
- Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years.
- Current or former smoker or use of tobacco in any form
- History of periodontal treatment in last 2 years
- Crowding in anterior teeth.
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 |
|---|---|---|
| Scaling and root planingScaling and root planing involves removal of plaque and calculus on tooth surface. | Procedure or surgery | Thick periodontal phenotype, Thin periodontal phenotype |
Primary outcome
Probing pocket depth
Time frame: 6 months
Change in pocket probing depth from baseline to 6 months
BLEEDING ON POCKET PROBING (BOPP)
Time frame: 6 months
Change in bleeding on pocket probing depth from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- 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.
Krishan Kant, BDS principal investigator
POST GRADUATE INSTITUTE OF DENTAL SCIENCES 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 Scaling and root planing 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 1 inclusion and 7 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 8 Jul 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 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 Rajinder Kr Sharma, MDS (9416358222, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: 6 months). The study lists 2 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 8 Jul 2022.