| CTRI Number |
CTRI/2024/11/077032 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effect of non surgical periodontal treatment on patients at risk of Cardiovascular disease. |
|
Scientific Title of Study
|
Effect of Nonsurgical Periodontal Treatment on Carotid Intima Media Thickness (c - IMT) and Cardiovascular Risk Biomarkers in stage II, III Periodontitis at Risk of Atherosclerotic Cardiovascular Disease (ASCVD) –
A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Sumit Sonpimpale |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
212, Department of Periodontology, Government Dental College and Hospital, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9766390385 |
| Fax |
|
| Email |
drpallavisonpimpale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
212, Department of Periodontology, Government Dental College and Hospital, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
212, Department of Periodontology, Government Dental College and Hospital, Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Nagpur, Medical College Premises, Medical Square, Nagpur-440003.(Maharashtra) |
|
|
Primary Sponsor
|
| Name |
Department of Periodontology, Government Dental College and Hospital, Nagpur |
| Address |
Govt. Dental College & Hospital, Medical College Premises, Medical Square, Nagpur-440003. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pallavi Sonpimpale |
Government Dental College and Hospital, Nagpur |
Room no. 212, second floor, Department of Periodontology, Govt. Dental College & Hospital, Medical College Premises, Medical Square, Nagpur-440003.
Nagpur
MAHARASHTRA |
9766390385
drpallavisonpimpale@gmail.com |
| Dr Pallavi Sonpimpale |
Government Medical College and Hospital Nagpur |
Department of Radio Diagnosis, ground floor, Government Medical College and Hospital, Medical Square, Nagpur 440003
Nagpur
MAHARASHTRA |
09766390385
drpallavisonpimpale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Hospital Nagpur |
Approved |
| Institutional Ethics Committee Government Dental College and Hospital Nagpur |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Full mouth disinfection (FMD) |
- Administration of local anesthesia [lidocaine (1%) with epinephrine], if needed.
- Full mouth scaling and root planing with hand and ultrasonic instruments completed over two consecutive days within 24 hours.
- Tongue brushing with a 1% chlorhexidine gel (1 minute)
- Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
- Subgingival chlorhexidine (1%) irrigation in all pockets
- Twice daily rinsing with chlorhexidine (1 minute) during fourteen days after the periodontal intervention
• Oral hygiene instructions on mechanical plaque control (Brushing technique demonstration and use of dental floss) – both orally and written, will be given to both the groups.
• Dental extractions will be performed only in cases of teeth that could not be preserved.
Total duration of intervention - two consecutive days |
| Comparator Agent |
Scaling Root planing (SRP) |
SRP per quadrant (30 minutes each) with hand and ultrasonic instrument will be done with weekly intervals between sessions. Total duration of intervention - four weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Stage II or Stage III Periodontitis subjects not at risk of ASCVD with CIMT ≥ 0.6 mm or elevated cardiovascular risk biomarkers.
Stage II Periodontitis – Moderate Periodontitis with Clinical Attachment Loss of 3 to 4 mm, Maximum probing depth ≤5 mm, mostly horizontal bone loss in Coronal third (15% to 33%).
Extent and distribution – Generalized.
Stage III Periodontitis - Severe Periodontitis with Clinical Attachment Loss of ≥5 mm, Radiographic bone loss extending to mid-third of root and beyond, Probing depth ≥6 mm, Vertical bone loss ≥3 mm, Furcation involvement Class II or III, Moderate ridge defect.
Extent and distribution – Generalized.
2. Stage II or Stage III Periodontitis subjects at risk of ASCVD with Borderline - high cholesterol or pre – hypertensive or prediabetic with CIMT ≥ 0.6 mm or elevated cardiovascular risk biomarkers.
3. Have at least 16 natural teeth excluding third molars.
Prehypertensive/ High – normal Blood Pressure (BP) - Subjects with systolic BP of 130-139 mmHg or diastolic BP of
85-89 mmHg.
2. Borderline - high cholesterol - Total serum cholesterol levels between 200 – 239 mg/dl or LDL (Low Density Lipoprotein) levels between 130 – 159 mg/dl.
3. Pre-diabetes - Subjects with prediabetes are defined by the presence of Fasting Plasma Glucose (FPG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) Impaired Fasting Glucose (IFG) and/or HbA1c 39 – 46 mmol/ mol (5.7-6.4 %).
4. Provide informed consent and willingness to cooperate with the study protocol |
|
| ExclusionCriteria |
| Details |
1. Treatment with antihypertensive, antilipemic, antiarrhythmic, anti-platelet therapy and other cardiovascular drugs.
2. Systemic diseases such as HIV/AIDS, liver disease, chronic renal failure, tuberculosis, autoimmune diseases, any mental disability.
3. Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, AV blockade, peripheral vascular disease, and cerebrovascular accident.
4. Subjects with hypercholesteremia, Diabetes Mellitus, Obesity, Smokers.
5. Oral/ Dental infections other than periodontal infections.
6. Subjects who received periodontal treatment within the last 6 months.
7. Subjects who require antibiotic prophylaxis before examination or treatment.
8. Pregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Carotid Intima Media Thickness (c-IMT)
2. Endocan/ Endothelium Specific Molecule – 1 (ESM-1)
3. Platelet Indices
4. Highly sensitive C-reactive protein (hs - CRP)
in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure (BP) in Prehypertensive Stage II or Stage III Periodontitis subjects |
Baseline, 3, 6, 9 and 12 months |
| Lipid Profile in Borderline - high cholesterol Stage II or Stage III Periodontitis subjects |
Baseline, 3,6,9 and 12 months |
| blood glucose level in prediabetic Stage II or Stage III Periodontitis subjects |
Baseline, 3,6,9 and 12 months |
| Bleeding on Probing (BOP)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
| Plaque Index (PlI)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
| Gingival Index (GI) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
| Probing Pocket Depth (PPD) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
| Clinical Attachment Level (CAL) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
| Gingival Recession (GR) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis. |
Baseline, 3,6,9 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
India has one of the highest burdens of cardiovascular disease (CVD) worldwide. According to the World Health Organization, India accounts for one-fifth of these deaths worldwide especially in younger population. CVDs strike Indians a decade earlier than the western population. Chronic infections accelerate vascular inflammation and promote thrombosis of vascular vessels and are believed to be a secondary pathogenic pathway. Periodontitis is an infectious disease resulting in inflammation within the supporting tissues of teeth resulting in progressive attachment and alveolar bone loss. Overall prevalence of Periodontitis is 47.2% in Indian population. There are two reasons why Periodontitis and CVD are believed to be related. Firstly, the levels of systemic inflammation increase when moderate or severe periodontitis is present. Secondly, the periodontal bacteria may invade the damaged periodontal tissue, enter the bloodstream and further invade the cardiovascular system. There is evidence for a strong association between Periodontitis and CVD, but a direct causal relationship has not been established. There is scarcity of information about whether periodontal treatment is able to reduce the risk for cardiovascular disease in periodontitis subjects. Hence, this Randomized controlled trial is designed to test the effect of nonsurgical periodontal treatment on Carotid Intima media thickness (c - IMT) and cardiovascular risk biomarkers viz., Endocan, Platelet indices and Highly sensitive C- Reactive Protein (hs-CRP) in subjects diagnosed with stage II or stage III Periodontitis at risk or not at risk of Atherosclerotic Cardiovascular Disease (ASCVD), with follow-up time of at least one year. The patients considered at risk for ASCVD will be borderline cholesterol level, pre – diabetes and pre – hypertension subjects. In addition, we will also see changes in Blood Pressure (BP) in Prehypertensive, Lipid Profile in Borderline - high cholesterol, blood glucose level in prediabetic subjects. Also, periodontal parameters will be assessed. |