| CTRI Number |
CTRI/2020/01/022921 [Registered on: 23/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Scaling and Root planing on the Clinical and Inflammatory Parameters in bleeding gums patients with and without Obesity. |
|
Scientific Title of Study
|
“A Comparative Evaluation of Effect of Non-surgical Periodontal
Therapy on the Clinical and Inflammatory Parameters -high sensitivity
C-Reactive Protein in Chronic Periodontitis Patients with and without
Obesity – A Controlled Clinical Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWARALI NANASAHEB NAGARE |
| Designation |
2nd year PG Student |
| Affiliation |
Govt. Dental College and Hospital, Aurangabad |
| Address |
Department no. - 154, Govt. Dental College and Hospital Aurangabad, Ghati campus, Panchakki road, Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8975887889 |
| Fax |
|
| Email |
n.swarali.sn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAYA SANJIV INDURKAR |
| Designation |
HOD and Professor |
| Affiliation |
Govt. Dental College and Hospital, Aurangabad |
| Address |
Department no. - 154, Govt. Dental College and Hospital Aurangabad, Ghati campus, Panchakki road, Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9823182694 |
| Fax |
|
| Email |
mayaindurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAYA SANJIV INDURKAR |
| Designation |
HOD and Professor |
| Affiliation |
Govt. Dental College and Hospital, Aurangabad |
| Address |
Department no. - 154, Govt. Dental College and Hospital Aurangabad, Ghati campus, Panchakki road, Aurangabad, Maharashtra
MAHARASHTRA
431001
India |
| Phone |
9823182694 |
| Fax |
|
| Email |
mayaindurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SWARALI NANASAHEB NAGARE
Depart.No. 154, first floor, Govt. Dental College, Ghati Campus, Panchakki Road, Aurangabad 431001 |
|
|
Primary Sponsor
|
| Name |
SWARALI NANASAHEB NAGARE |
| Address |
Department no. - 154, Govt. Dental College and Hospital Aurangabad, Ghati campus, Panchakki road, Aurangabad, Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SWARALI NANASAHEB NAGARE |
Govt. Dental College and Hospital, Aurangabad |
Department no. - 154, Govt. Dental College and Hospital Aurangabad, Ghati campus, Panchakki road, Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA |
8975887889
n.swarali.sn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, (2) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-Surgical Periodontal Therapy in Non-Obese patients |
Non-Surgical Periodontal Therapy will be given to Chronic Periodontitis Non-Obese patients at baseline followed by assessment of Clinical and Inflammatory Parameters -high sensitivity C-Reactive Protein at baseline and 2 months after therapy. |
| Comparator Agent |
Non-Surgical Periodontal Therapy in Obese patients |
Non-Surgical Periodontal Therapy will be given to Chronic Periodontitis Obese patients at baseline followed by assessment of Clinical and Inflammatory Parameters -high sensitivity C-Reactive Protein at baseline and 2 months after therapy. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Normal weight patients [body mass index (BMI) ≤30kg/sq.m, waist-hip ratio (WHR)≤0.8 for women and ≤0.9 for men, waist circumference (WC)<88 cm for women and <102 cm for men, and percentage of body fat (BF)≤35% for women and ≤25% for men] with moderate to severe chronic periodontitis.
2.Obese patients [body mass index (BMI) ≥ 30 kg/sq.m ; waist-hip ratio (WHR) ≥0.8 for women and ≥0.9 for men; waist circumference (WC) >88 cm for women and >102 cm for men; percentage of body fat (BF) ≥35% for women and ≥25% for men]
with moderate to severe chronic periodontitis.
3.Patients with no history of any periodontal treatment 6 months prior to the study.
4.Patients willing to give and sign written informed consent for study. |
|
| ExclusionCriteria |
| Details |
1.Patients with any systemic disease other than Obesity,
2.Patients on antibiotic or antimicrobial therapy,
3.Smokers and smokeless tobacco users,
4.Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Non-surgical Periodontal Therapy on the Clinical and Inflammatory Parameters -high sensitivity C-Reactive Protein in Chronic Periodontitis Patients with and without Obesity |
At baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effects of non-surgical periodontal
therapy on clinical parameter like Plaque index (PI), Gingival index (GI),Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) in obese and
normal weight patients with moderate to severe chronic
periodontitis. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
27/01/2020 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Comparative Evaluation of Effect of Non-surgical Periodontal Therapy on the Clinical and Inflammatory Parameters -high sensitivity C-Reactive Protein in Chronic Periodontitis Patients with and without Obesity. PURPOSE: RATIONALE: C-reactive protein (CRP) is an acute phase reactant plasma protein produced in response to diverse inflammatory stimuli. CRP is associated with endothelial cell damage and it has been viewed as a marker of low-grade vascular inflammation. Several lines of evidence suggest that obesity is a low-grade systemic inflammatory condition accompanied by increased levels of circulating CRP and other inflammatory cytokines such as TNF alpha and IL-6. Periodontitis is defined as “an inflammatory disease of the supporting tissues of the teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with increased probing depth formation, recession, or both.†Non-surgical periodontal therapy (NSPT) remains the gold standard in the management of chronic periodontitis (CP). NSPT involves mechanical removal of bacterial biofilm and deposit with scaling and root planing (SRP), creating a local environment and microbiota harmonious with the periodontal health. Al-Zahrani & Alghamdi (2012)concluded that Periodontal treatment is effective in reducing systemic inflammation as measured by serum CRP level and obesity does not have a major negative impact on response to periodontal therapy.
PURPOSE: Several studies have examined periodontal outcomes after nonsurgical periodontal treatment (NSPT) for CP in obese patients. Although some studies reported that obesity did not affect clinical attachment gain or Probing Pocket Depth (PPD) reduction after periodontal treatment, other studies showed that patients with a higher Body Mass Index (BMI)had a poorer response to NSPT. Al-Zahrani & Alghamdi (2012)concluded that Periodontal treatment is effective in reducing systemic inflammation as measured by serum CRP level and obesity does not have a major negative impact on response to periodontal therapy. Hence, the objective of this study is to evaluate the effect of non-surgical periodontal therapy on the periodontal parameters and serum levels of high sensitivity C-Reactive Protein (hs-CRP) in obese & normal weight patients affected with moderate to severe periodontitis. |