| CTRI Number |
CTRI/2018/08/015327 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Instruction for pulp therapy done purposefully in patients with severe bone loss around the tooth. |
|
Scientific Title of Study
|
Guidelines forsuggesting intentional root canal therapy in patients with severe periodontal bone loss. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Shivaprasad BM |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari dental college and hospital |
| Address |
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901759011 |
| Fax |
|
| Email |
drspbmath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Shivaprasad BM |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari dental college and hospital |
| Address |
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9901759011 |
| Fax |
|
| Email |
drspbmath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Geetha K |
| Designation |
PG Student |
| Affiliation |
Rajareshwari dental college and hospital |
| Address |
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9591085656 |
| Fax |
|
| Email |
geethagee000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari dental college and hospital |
|
|
Primary Sponsor
|
| Name |
DR SHIVAPRASAD BM |
| Address |
Department of Periodontology, Room no.4, Rajarajeswari Dental College and Hospital, Mysore road, Ramohalli Cross, Bangalore |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Shivaprasad BM |
Rajarajeshwari dental college and hospital |
Department of periodontology, room no 4, Rajarajeswari dental college and hospital, bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9901759011
drspbmath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderate to advanced chronic periodontitis patients, of clinical attachment level(CAL)>3mm in 30% or more sites.
2. Well-aligned mandibular molars with the radiographic evidence of bone loss extending beyond the root apex, no spacing, no crowding, no rotation and no intrusion and no extrusion were included.
3.Patients between the age group of 25-70 years.
4.Patients who were willing to consent for the study.
|
|
| ExclusionCriteria |
| Details |
•Systemic diseases that can alter the course of periodontal disease.
•Subjects on any medication taken within last 6 months which may alter the periodontal status.
•Pregnant women.
•Molars with fused roots, caries and proximity to maxillary sinus
•Subjects with limited mouth opening
•Patients with intra oral conditions present that interfere with radiographic evaluation such as orthodontic wire, extensive restorative work, shallow palatal vault.
•Single rooted teeth with extensive bone loss and poor prognosis.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The amount of bone loss beyond the root apex and the amount of residual bone in tooth with severe periodontal bone loss, irrespective of root canal treatment. |
Patients who did not undergo intentional root canal therapy was assessed at 6 weeks postperiodontal therapy for any developed secondary endodontic signs and symptoms. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The amount of bone loss beyond the root apex and the amount of residual bone in tooth with severe periodontal bone loss, irrespective of root canal treatment. |
Patients who did not undergo intentional root canal therapy was assessed at 6 weeks postperiodontal therapy for any developed secondary endodontic signs and symptoms. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
13/08/2018 |
| 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
|
NO publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Iatrogenic pulpitis can occur following the periodontal treatment of tooth with severe periodontal bone loss involving the apex. This might lead to anxiety and apprehension in the minds of patients and may force the patient to feel that periodontal treatment has led to the endodontic problem. To allay the anxiety of future endodontic problem, there is a need for periodontist to suggest for intentional root canal therapy in patients with severe periodontal bone loss extending upto the apex of the root. This study is aimed to provide guidlines for suggesting intentional root canal therapy in patients with severe periodontal bone loss. A total of 105 chronic generalised periodontitis patients were assessed. With the help of radiovisography(RVG) ,the distance between the root apex and the residual bone was measured and pulp vitality test was carried out on respective tooth with the bone loss. All patients underwent periodontal treatment according to the treatment needs.Patients who did not undergo intentional root canal therapy was evaluated 6 weeks later after periodontal treatment to assess the development of secondary endodontic signs and symptoms. The mean distance between the root apex and the base of the residual bone of the tooth with severe periodontal bone loss was -2.007±0.495mm in patients who underwent root canal therapy and -1.311±1.574mm in patients who did not undergo root canal therapy. |