PeriodontitisSRPNCT05449964
Single Sitting SRP vs Supra-gingival Scaling Followed by Sub-gingival SRP After One Week
A study testing SCALING AND ROOT PLANING (SRP)in single sitting and SCALING AND ROOT PLANING (SRP)in two sittings in people with Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The primary course of periodontal treatment is non-surgical periodontal therapy followed by surgical therapy, if required, with an aim to arrest ongoing inflammatory periodontal destruction along with reconstruction of lost apparatus if possible. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- SCALING AND ROOT PLANING (SRP)in single sitting and SCALING AND ROOT PLANING (SRP)in two sittings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to Nov 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- •Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.
Who cannot join
- Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- Mobile teeth (Mobility no. 2 and 3 as per Miller Index)
- Patient taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to interfere with periodontal wound healing.
- Pregnant or lactating women.
- History of use of tobacco.
- History of periodontal treatment in last 2 years.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Sanjay Tewari, 01262283876, principalpgids@yahoo.in
Ambika Gupta
About this study
Official title: Comparative Evaluation of Outcomes of Single Sitting Scaling and Root Planing (SRP) vs Supra-gingival Scaling Followed by Sub-gingival Scaling and Root Planing After One Week: a Split-mouth Randomised Controlled Clinical Trial
The primary course of periodontal treatment is non-surgical periodontal therapy followed by surgical therapy, if required, with an aim to arrest ongoing inflammatory periodontal destruction along with reconstruction of lost apparatus if possible. There is no protocol established for completing scaling and root planing (SRP) in patients with generalized advanced periodontitis. In some cases SRP is completed in single sitting whereas in other cases supragingival scaling is followed by subgingival SRP in the next appointment. It is hypothesized that presence of reparative components near the base of the pocket could result in better treatment outcomes after scaling and root planning done in single sitting when compared to supragingival scaling followed by sub-gingival scaling and root planning after one week.
Read the detailed description
The aim of this randomized controlled clinical trial is to clinically compare the outcomes of scaling and root planing (SRP) completed in single sitting vs supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
OBJECTIVES:
- To assess the improvement in clinical parameters viz. bleeding on pocket probing (BOPP), pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on marginal probing (BOMP), gingival marginal position (GMP) and gingival recession (GR) by single sitting scaling and root planning versus supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
- To assess the correlation between availability of Vascular Endothelial Growth Factor (VEGF) at the base of the pocket and treatment outcomes.
SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Split-mouth Randomized controlled clinical trial.
TIME FRAME: 12 months
POPULATION: Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.
SAMPLE SIZE: To be able to detect a clinically meaningful difference of 1mm and 10% improvement in PPD and BOPP respectively between groups, assuming an effect size of 0.85 with a power of 80% and 5% level of significance, a minimum sample size of 22 patients are needed in each group. Accounting for a 20% drop out rate, 27 patients are needed in each group.
METHODOLOGY: Patients with stage II and III generalised periodontitis will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent. A split-mouth design will be chosen using two contra-lateral quadrants per group being randomly assigned into test (single sitting SRP) and control (supragingival scaling followed by subgingival scaling after a week) group for each patient using a chit-method.
- Conditions
- Periodontitis
- Being tested
- SCALING AND ROOT PLANING (SRP)in single sitting, SCALING AND ROOT PLANING (SRP)in two sittings
- 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 PLANING (SRP)in single sittingProcedure or surgery
SCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING.
SCALING AND ROOT PLANING (SRP)in two sittingsProcedure or surgery
SCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING.
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Experimental | INTERVENTION: Scaling and root planning (SRP) of two contra-lateral quadrants (randomly allocated) in single sitting with ultrasonic scaler, hand scalers and curettes under local anaesthesia. Receives: Procedure: SCALING AND ROOT PLANING (SRP)in single sitting |
| CONTROL GROUP | Active comparator | INTERVENTION: Supra-gingival scaling followed by sub-gingival scaling and root planing of two contra-lateral quadrants (randomly allocated) in two sittings with ultrasonic scaler, hand scalers and curettes under local anaesthesia. Receives: Procedure: SCALING AND ROOT PLANING (SRP)in two sittings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bleeding on pocket probing (BOPP)
CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS
Measured: 6 MONTHS
Chane in pocket probing depth (PPD)
CHANGE IN 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 Aug 2021
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AANCHAL SAHNI, BDS, Principal investigator, POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449964
- Sponsor's protocol ID
- AANCHAL SAHNI PERIO
- Acronym
- SRP
- Status last verified
- Jul 2022
- First submitted
- 28 May 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahni A, Sharma RK, Tewari S, Gill PS, Arora R. Impact of supragingival scaling on the outcomes of subgingival instrumentation completed after 1 week: a split-mouth randomized clinical trial. Quintessence Int. 2023 Oct 19;54(9):724-733. doi: 10.3290/j.qi.b4168461.
PubMed 37334784
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Outcomes of Single Sitting Scaling and Root Planing (SRP) vs Supra-gingival Scaling Followed by Sub-gingival Scaling and Root Planing After One Week: a Split-mouth Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05449964
- Acronym / sponsor ID
- SRP / AANCHAL SAHNI PERIO
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 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.
The primary course of periodontal treatment is non-surgical periodontal therapy followed by surgical therapy, if required, with an aim to arrest ongoing inflammatory periodontal destruction along with reconstruction of lost apparatus if possible. There is no protocol established for completing scaling and root planing (SRP) in patients with generalized advanced periodontitis. In some cases SRP is completed in single sitting whereas in other cases supragingival scaling is followed by subgingival SRP in the next appointment. It is hypothesized that presence of reparative components near the base of the pocket could result in better treatment outcomes after scaling and root planning done in single sitting when compared to supragingival scaling followed by sub-gingival scaling and root planning after one week.
Detailed description
The aim of this randomized controlled clinical trial is to clinically compare the outcomes of scaling and root planing (SRP) completed in single sitting vs supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
OBJECTIVES:
- To assess the improvement in clinical parameters viz. bleeding on pocket probing (BOPP), pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on marginal probing (BOMP), gingival marginal position (GMP) and gingival recession (GR) by single sitting scaling and root planning versus supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
- To assess the correlation between availability of Vascular Endothelial Growth Factor (VEGF) at the base of the pocket and treatment outcomes.
SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.
STUDY DESIGN: Split-mouth Randomized controlled clinical trial.
TIME FRAME: 12 months
POPULATION: Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.
SAMPLE SIZE: To be able to detect a clinically meaningful difference of 1mm and 10% improvement in PPD and BOPP respectively between groups, assuming an effect size of 0.85 with a power of 80% and 5% level of significance, a minimum sample size of 22 patients are needed in each group. Accounting for a 20% drop out rate, 27 patients are needed in each group.
METHODOLOGY: Patients with stage II and III generalised periodontitis will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent. A split-mouth design will be chosen using two contra-lateral quadrants per group being randomly assigned into test (single sitting SRP) and control (supragingival scaling followed by subgingival scaling after a week) group for each patient using a chit-method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | Experimental | Procedure: SCALING AND ROOT PLANING (SRP)in single sittingINTERVENTION: Scaling and root planning (SRP) of two contra-lateral quadrants (randomly allocated) in single sitting with ultrasonic scaler, hand scalers and curettes under local anaesthesia. |
| CONTROL GROUP | Active comparator | Procedure: SCALING AND ROOT PLANING (SRP)in two sittingsINTERVENTION: Supra-gingival scaling followed by sub-gingival scaling and root planing of two contra-lateral quadrants (randomly allocated) in two sittings with ultrasonic scaler, hand scalers and curettes under local anaesthesia. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- •Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.
Key exclusion criteria (6 listed)
- Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- Mobile teeth (Mobility no. 2 and 3 as per Miller Index)
- Patient taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to interfere with periodontal wound healing.
- Pregnant or lactating women.
- History of use of tobacco.
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 PLANING (SRP)in single sittingSCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING. | Procedure or surgery | TEST GROUP |
| SCALING AND ROOT PLANING (SRP)in two sittingsSCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING. | Procedure or surgery | CONTROL GROUP |
Primary outcome
Change in bleeding on pocket probing (BOPP)
Time frame: 6 MONTHS
CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS
Chane in pocket probing depth (PPD)
Time frame: 6 MONTHS
CHANGE IN 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 28 Sep 2022.
- Derived from this study: PubMed 37334784Sahni A, Sharma RK, Tewari S, Gill PS, Arora R. Impact of supragingival scaling on the outcomes of subgingival instrumentation completed after 1 week: a split-mouth randomized clinical trial. Quintessence Int. 2023 Oct 19;54(9):724-733. doi: 10.3290/j.qi.b4168461.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
RecruitingObservational study
Candida Albicans in Syrian Patients With Periodontitis
Periodontal Disease, Periodontal Diseases
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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.
AANCHAL SAHNI, 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 (SRP)in single sitting and SCALING AND ROOT PLANING (SRP)in two sittings 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 6 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 28 Sep 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 (01262-283876, rksharmamds@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bleeding on pocket probing (BOPP) (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?
On the ClinicalTrials.gov record for NCT05449964, which also lists 1 linked publication.
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 28 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.