| CTRI Number |
CTRI/2026/04/107480 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessment of erythrocytes and hemoglobin levels in gum disease patients before and after teeth cleanig and gum surgery. |
|
Scientific Title of Study
|
ASSESSSMENT OF ERYTHROCYTES AND HEMOGLOBIN LEVELS AFTER PERIODONTAL THERAPY IN
PATIENTS WITH STAGE III PERIODONTITIS -A CLINICO-HEMATOLOGICAL STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garadala Pragna Sri |
| Designation |
Post Graduation Student |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
COORG INSTITUTE OF DENTAL SCIENCES, K K CAMPUS,MAGULLA VILLAGE, VIRAJPET, KARNATAKA 571218
,
Kodagu
KARNATAKA
571218
India |
| Phone |
07981713664 |
| Fax |
|
| Email |
vennelapragna3934@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garadala Pragna Sri |
| Designation |
Post Graduation Student |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
COORG INSTITUTE OF DENTAL SCIENCES,DEPARTMENT OF PERIODONTICS AND IMPANTOLOGY,ROOM NO-4,K K CAMPUS,MAGULLA VILLAGE, VIRAJPET, KARNATAKA,571218
Kodagu
KARNATAKA
571218
India |
| Phone |
07981713664 |
| Fax |
|
| Email |
vennelapragna3934@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi S Pattanshetty |
| Designation |
Reader |
| Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
| Address |
COORG INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY,ROOM N0-4, K K CAMPUS,MAGULLA VILLAGE, VIRAJPET, KARNATAKA, 571218
Kodagu
KARNATAKA
5717218
India |
| Phone |
09986187860 |
| Fax |
|
| Email |
rashmi2bs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences,Department of Periodontics and Implantology,Kanjithanda Kushalappa Campus ,Maggula, Virajpet -571718, Kodagu,Karnataka. |
|
|
Primary Sponsor
|
| Name |
Dr Garadala Pragna Sri |
| Address |
COORG INSTITUTE OF DENTAL SCIENCES, K K CAMPUS,
MAGULLA VILLAGE, VIRAJPET, KARNATAKA, 571218
Kodagu
India |
| 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 |
| Dr Garadala Pragna Sri |
Coorg Institute of Dental Sciences |
COORG INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF PERIODNTICS AND IMPLANTOLOGY,ROOM N0-4, K K CAMPUS,
MAGULLA VILLAGE, VIRAJPET, KARNATAKA,
571218
India
Kodagu
KARNATAKA |
7981713664
vennelapragna3934@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board,Coorg Institute of Dental Sciences |
Approved |
|
|
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 |
| Comparator Agent |
Baseline- erythrocyte and hemoglobin levels of the same patients. |
Baseline -erythrocyte count and hemoglobin levels of the same patients before periodontal therapy.
|
| Intervention |
Patients with Stage III periodontitis receiving periodontal therapy scaling and root planing followed by flap surgery. |
Patients with Stage III periodontitis will receive periodontal therapy consisting of scaling and root planing followed by flap surgery. Erythrocyte count and hemoglobin levels will be recorded at baseline, 1 month after scaling and root planing, and 3 months after flap surgery to assess the effect of periodontal treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age between 18 and 45 years
2. Patients with stage III periodontitis.
3. Patients with radiographic evidence of bone loss.
4. Patients with hemoglobin levels women with hemoglobin of less than 12 g/dl and men With hemoglobin of less than13 g/dl. |
|
| ExclusionCriteria |
| Details |
1. Current or previous smokers and alcoholics.
2. History of treatment for periodontal disease or use of antimicrobial agents in the previous six months.
3. Patients with any other systemic diseases.
4. Pregnant, menopausal, or lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate erythrocytes and hemoglobin levels in patients with stage 3 periodontitis at 3 intervals .(baseline ,1 month after scaling and rootplaning and 3 months after flap surgery). |
To evaluate erythrocytes and hemoglobin levels in patients with stage 3 periodontitis at 3 intervals .(baseline ,1 month after scaling and rootplaning and 3 months after flap surgery). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare erythrocytes and hemoglobin levels in patients with stage 3 periodontitis at 3 intervals .(baseline ,1 month, after scaling and rootplaning and 3 months after flap surgery). |
All clinical parameters wiil be measured and blood samples collection will be done at baseline,1 month after scaling and rootplaning and 3 months after flap surgery. |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="3"
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
Modification(s)
|
This clinico-hematological study assessed the effect of non-surgical periodontal therapy on erythrocyte count and hemoglobin levels in patients with Stage III periodontitis. A total of diagnosed Stage III periodontitis patients were selected based on predefined inclusion and exclusion criteria. Baseline clinical periodontal parameters and hematological parameters, including erythrocyte count and hemoglobin levels, were recorded. All participants underwent non-surgical periodontal therapy consisting of scaling and root planing. Hematological assessments were repeated after periodontal therapy to evaluate changes. The results showed an improvement in erythrocyte count and hemoglobin levels following treatment, indicating a reduction in systemic inflammatory effects associated with periodontitis. This study emphasizes the positive impact of periodontal therapy on both periodontal health and systemic hematological parameters, supporting the interrelationship between periodontal disease and overall health. |