| CTRI Number |
CTRI/2017/12/010727 [Registered on: 01/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/02/2022 |
| 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 gum treatment on a acute phase protein and iron indices in periodontitis patients undergoing haemodialysis |
|
Scientific Title of Study
|
Effect of nonsurgical periodontal therapy on C-reactive protein and iron indices in haemodialysis patients with chronic periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheethel Menon V |
| Designation |
Post Graduate Student |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Padanilam, Kulasekharam,
Kanyakumari District
Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9445678206 |
| Fax |
|
| Email |
sheethel.menon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Sadasivan |
| Designation |
Professor |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Padanilam, Kulasekharam,
Kanyakumari District
Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9847246961 |
| Fax |
|
| Email |
sadasivan_arun@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Sadasivan |
| Designation |
Professor |
| Affiliation |
Sree Mookambika Institute of Dental Sciences |
| Address |
Department of Periodontics and Oral Implantology,
Padanilam, Kulasekharam,
Kanyakumari District
Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9847246961 |
| Fax |
|
| Email |
sadasivan_arun@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funding. Funding was by the primary investigator |
|
|
Primary Sponsor
|
| Name |
Sheethel Menon V |
| Address |
Department of Periodontics and oral implantology
Sree Mookambika Institute of Dental Sciences.
Kulasekaram - 629161
Kanyakumari District
Tamilnadu
|
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Sheethel Menon |
Sree Mookambika Institute of Dental Sciences |
Department of Periodontics and Oral Implantology, Kulasekharam - 629161
Kanniyakumari
TAMIL NADU |
9947020908
drsheethelmenon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, Group I - Chronic Periodontitis under hemodialysis for less than a year
Group II - Chronic Periodontitis under hemodialysis for more than a year
Group III - Chronic Periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients with Chronic periodontitis |
Scaling and Root Planing |
| Intervention |
Patients with Chronic Periodontitis and under hemodialysis for Less than a year |
Scaling will be done using ultrasonic instruments and root planing will be done with Gracey Curettes Edit || Delete
|
| Intervention |
Patients with Chronic Periodontitis and under hemodialysis for more than a year |
Scaling will be done using ultrasonic instruments and root planing will be done with Gracey Curettes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A. Group I: Renal patients undergoing haemodialysis for less than a year with chronic periodontitis
i. Patients with Chronic periodontitis will be diagnosed when there is attachment loss ≥5mm in more than 30% of teeth (according to the criteria of 1999 American Academy of Periodontology Workshop).
ii. Patients with more than or equal to 20 teeth
iii. Patients with clinical bleeding on probing.
iv. Patients undergoing haemodialysis for atleast 3months and less than a year.
B. Group II: 20 renal patients undergoing haemodialysis for more than a year with chronic periodontitis
i. Patients with Chronic periodontitis will be diagnosed when there is attachment loss ≥5mm in more than 30% of teeth (according to the criteria of 1999 American Academy of Periodontology Workshop).
ii. Patients with more than or equal to 20 teeth
iii. Patients with clinical bleeding on probing.
iv. Patients undergoing haemodialysis for more than a year.
C. Group III: 20 systemically healthy periodontitis patients
i. Patients with Chronic periodontitis will be diagnosed when there is attachment loss ≥5mm in more than 30% of teeth (according to the criteria of 1999 American Academy of Periodontology Workshop).
ii. Patients with more than or equal to 20 teeth
iii.Patients with clinical bleeding on probing.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with uncontrolled hypertension inspite of medication
2.Edentulous patients
3.Smokers, alcoholics, pregnant women and lactating mothers.
4.Patients needing prophylactic antibiotic medication in association with periodontal probing.
5.Patients who had undergone periodontal treatment in the past 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) C reactive protein level
2) Iron Indices - Serum Iron, Serum Ferritin, Total Iron binding capacity |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Plaque index
2) Gingival Index
3) Probing pocket depth
4) Clinical Attachment level |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2016 |
| Date of Study Completion (India) |
19/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chronic
periodontitis, a inflammatory disease of supporting tissues of teeth, is found
to increase the systemic inflammatory burden possibly facilitated by acute
phase reactants like C-reactive protein (CRP), which aggravates the existing
metabolic conditions like diabetes, hypertension and anemia in chronic kidney
disease(CKD) patients undergoing haemodialysis Aim of the study To
evaluate effect of non-surgical
periodontal therapy on clinical, renal and haematological parameters at
baseline and 3 months postoperatively. Materials and
Methods This
was a comparative interventional study. Sixty chronic periodontitis patients
were divided into three groups which consisted of CKD patients undergoing
haemodialysis for less than a year (Group I), CKD patients undergoing haemodialysis
for more than a year (Group II) and systemically healthy chronic periodontitis
patients(Group III). Clinical parameters
were recorded at baseline, 1 month and 3 months after nonsurgical periodontal
therapy. C reactive protein (CRP), transferrin saturation (TSAT) and serum
ferritin was observed at baseline and 3 months after nonsurgical periodontal
therapy. Results The
clinical parameters showed pronounced reduction at the end of 3 months in all
the groups. CRP reduced in all the three groups 3 months post-operatively, but
statistically significant reduction was seen in Group I and group III only.
TSAT increased significantly in all the three groups. With regard to serum
ferritin, it was seen that serum ferritin increased significantly in Group I
and Group II, whereas significant reduction was seen in Group III. Conclusion
It was noted that nonsurgical
periodontal therapy can bring about reduction in CRP level and also improvement
in iron indices in systemically healthy periodontitis patients and also in
chronic kidney disease patients undergoing haemodialysis of varying duration.
However studies with larger sample size and longer duration of follow up are
required to confirm the findings. |