| CTRI Number |
CTRI/2018/06/014426 [Registered on: 05/06/2018] Trial Registered Prospectively |
| Last Modified On: |
03/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A preliminary study is planned to check two different treatment options for the management of infection of the pulp in lower molar teeth. |
|
Scientific Title of Study
|
A preliminary study to evaluate the outcome of combination of non-surgical endodontic and vital pulp therapy for management of mature permanent molar teeth with symptomatic irreversible pulpitis and periapical rarefaction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Koli |
| Designation |
Junior resident |
| Affiliation |
Centre for Dental Education and Research, AIIMS, New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, AIIMS,Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
8802820778 |
| Fax |
|
| Email |
bhawna.koli09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Chawla |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Dental Education and Research, AIIMS, New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, AIIMS,Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Chawla |
| Designation |
Assistant Professor |
| Affiliation |
Centre for Dental Education and Research, AIIMS, New Delhi |
| Address |
Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, AIIMS,Ansari Nagar New Delhi
South
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Conservative Dentistry and Endodontics, Third floor, Centre for Dental Education and Research, AIIMS, Ansari Nagar, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
Centre for Dental Education and Research |
| Address |
AIIMS, Ansari Nagar, New Delhi- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhawna Koli |
Centre for Dental Education and Research |
Divison of Conservative Dentistry and Endodontics, third floor, CDER, AIIMS, New Delhi- 110029
South
DELHI |
8802820778
bhawna.koli09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with symptomatic irreversible pulpitis and periapical rarefaction in either of roots of mature permanent mandibular molar teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of non-surgical endodontic and vital pulp therapy |
The access to pulp chamber will be gained under local anaesthesia and aseptic conditions. Full pulpotomy (vital pulp therapy) will be performed. After haemostasis, mineral trioxide aggregate (MTA) will be placed 2-3 mm into the orifice of root canal with no periapical lesion and a layer of light cure Glass ionomer cement (GIC) will be placed over MTA.
The standard protocol for non-surgical endodontic procedure will be performed in the root with periapical lesion. The cavity will be sealed with definitive post endodontic restoration. Post obturation radiographs will be taken as baseline. Teeth will be followed up at every six months interval.
|
| Comparator Agent |
Non-sugical endodontic therapy |
The access to pulp chamber will be gained under local anaesthesia and aseptic conditions. The standard protocol for non-surgical endodontic procedure will be followed. The cavity will be sealed with definitive post endodontic restoration. Post obturation radiographs will be taken as baseline. Teeth will be followed up at every six months interval.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy patient of either gender between 18-35 years of age group.
2)Mandibular molar teeth with definitive clinical diagnosis of irreversible pulpitis with periapical involvement (PAI score ≥ 3) in either of the roots.
3)Positive response to cold and EPT testing.
4)The tooth is restorable.
5)Probing pocket depth and mobility are within normal limits.
|
|
| ExclusionCriteria |
| Details |
1)Teeth with definitive clinical diagnosis of Irreversible Pulpitis which are not associated with periapical rarefaction.
Intraoperative exclusion criteria:
1)Bleeding cannot be controlled within 6 mins with pressure pack.
2)Clinical diagnosis changes from symptomatic irreversible pulpitis to pulp necrosis.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical and radiographic periapical healing in mature permanent molar teeth with symptomatic irreversible pulpitis and periapical rarefaction after the following treatment procedures:
a.Non-surgical endodontic therapy
b.Combination of non-surgical endodontic and vital pulp therapy
|
6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome measurement |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
27/06/2018 |
| 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="1"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Evidence shows that at any given moment in a tooth
many different stages of disease process can be observed throughout the pulp. Specially for multi-rooted teeth, the clinical scenario becomes more
complex where one root shows periapical involvement while other root does not
show periapical involvement. It can be interpreted that there is a high chance
of pulp degeneration or necrosis in the root with periapical involvement which
should be treated by conventional non-surgical endodontic therapy (NSET) and the
root with vital pulp and no periapical involvement should be given a chance to
regenerate with vital pulp therapy (VPT). On these basis, a
treatment protocol of a combination of NSET and VPT is proposed for molar teeth
with symptomatic irreversible pulpitis and periapical rarefaction in either of
roots. This treatment modality will remove the diseased part and help in
preservation of healthy tissue, also maintain the vitality of the radicular
pulp and help in preservation of immunological functions and retaining
structural integrity of the tooth.
Two groups (Group I and Group II) will be defined on the
basis of the procedure done in molar teeth with symptomatic irreversible pulpitis and periapical
rarefaction in either of roots. A block randomization with variable
block size will be used to generate sequence of random number for allocation of
teeth to one of the two groups. Each random number will be kept in an opaque
envelop which would be opened at the time of allocation of teeth in one of the
two group. The subjects will be blinded throughout the study. Sixty teeth will
be distributed into the pre-determined study groups as follows:
Group-
I: Non-Surgical Endodontic Therapy
Group- II: Combination of Non-Surgical Endodontics and
Vital Pulp Therapy
The teeth will be evaluated
clinically and radiographically. The patient will be reviewed after every 6
months for the study period. The review radiographs will be taken at 6-month
and 12-month interval. Tenderness to palpation, percussion, presence of
swelling and the absence/presence of sinus will be assessed. Appropriate
statistical test would be applied to the data generated.
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