| CTRI Number |
CTRI/2015/05/005748 [Registered on: 05/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
30/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of three suturing techniques on distal surface of 2nd molar after the surgical removal of impacted mandibular third molar for the prevention of periodontal problem to 2nd molar |
|
Scientific Title of Study
|
Comparative evaluation of three suturing techniques on periodontal health of distal surface of 2nd molar after mandibular 3rd molar surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Bali |
| Designation |
reader |
| Affiliation |
M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala |
| Address |
room no- 2, department of oral and maxillofacial surgery.
m.m. college of dental sciences and research, mullana, ambala
Ambala
HARYANA
133203
India |
| Phone |
9466302336 |
| Fax |
|
| Email |
amitbaliomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Bali |
| Designation |
reader |
| Affiliation |
M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala |
| Address |
room no-2, department of oral and maxillofacial surgery. M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
09812020331 |
| Fax |
|
| Email |
amitbaliomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Bali |
| Designation |
reader |
| Affiliation |
M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala |
| Address |
room no-2, department of oral and maxillofacial surgery. M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9466302336 |
| Fax |
|
| Email |
amitbaliomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.M. College of Dental Sciences and Research, M.M.University,Mullana, Ambal |
|
|
Primary Sponsor
|
| Name |
MM College of Dental Sciences and Research |
| Address |
M.M. College of Dental Sciences and Research, M.M.University, Mullana, Ambala, Haryana, India |
| Type of Sponsor |
Other [private dental college] |
|
|
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 Amit Bali |
M.M.College of Dental Sciences and Research |
room no-2, department of oral and maxillofacial surgery. M.M.College of Dental Sciences and Research, M.M. University, Mullana, Ambala
Ambala
HARYANA |
09466302336
amitbaliomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, maharishi markandeshwar university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
sutures |
three suturing techniques of interrupted, anchor and close anchor were compared in this study by using 3-0 black silk sutures on the distal surface of mandibular 2nd molar after the surgical removal of impacted mandibular 3rd molar |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age of 16 to 30 year.
2. Patients with good general health (ASA Class I & II) and without any contraindication for oral surgery &/ or local anaesthesia.
3. Having bilateral impacted mandibular 3rd molar.
4. Periodontally healthy patients.
|
|
| ExclusionCriteria |
| Details |
1. Patient with systemic condition that according to the investigator would preclude surgery.
2. Patient with acute infectious lesion in areas intended for surgery
3. Participation of the patient in other clinical trials
4. Patient who is not willing to participate
5. Alcohol or drug abuse or any condition associated with poor compliance
6. Pregnant or lactating mother
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
. The following local periodontal parameters of the mandibular 2nd molar were recorded at the distobuccal, middistal, and distolingual surface
1. Probing pocket depth (PPD)
2. Clinical attachment level (CAL)
3. Bleeding Index (BI)
4. Plaque Index(PI)
|
from April 2011 to March 2013 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. The following local periodontal parameters of the mandibular 2nd molar were recorded at the distobuccal, middistal, and distolingual surface
1. Probing pocket depth (PPD)
2. Clinical attachment level (CAL)
3. Bleeding Index (BI)
4. Plaque Index(PI)
|
after 6month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background- Third molars
are the most common impacted teeth. Therefore, removal of third molar is the
most common minor surgical procedure in the oral cavity. Periodontal pocket
distal to mandibular second molar is one of the important complications after
mandibular third molar removal.
Methods-This randomized
controlled clinical trial was designed to compare the efficacy of three
different suturing techniques of Interrupted, anchor, and close anchor suture.
Thirty patients having bilateral impacted mandibular third molar participated
in this study. All patients were divided
into three groups. In Group 1, surgical wound distal to 2nd
mandibular molar was closed by interrupted suture technique on one side &
anchor suture technique on the opposite side. In Group 2, surgical wound was
closed by interrupted suture technique on one side & close anchor suture
technique on the opposite side. In Group 3, surgical wound was closed by anchor
suture technique on one side & close anchor suture technique on the
opposite side.
Results – comparison of
the pre and post operative plaque index in three suturing technique has shown
lowest plaque index score in anchor suture area (p<0.05). Bleeding index has
shown statistically significant decreased post operative score in anchor suture
group. Post operative pocket depth was lowest in interrupted suture area as
compare to anchor and closed anchor suture area. Comparison of the pre and post
operative clinical attachment level has minimally changed in anchor suture as
compare to interrupted and closed anchor suture technique.
Conclusion- In our study,
anchor suture seems to be slightly better as compare to interrupted and closed
anchor suture technique. |