| CTRI Number |
CTRI/2024/10/074958 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the healing of wound after removal of impacted lower wisdom tooth with and without stitching . |
|
Scientific Title of Study
|
Comparative evaluation of the healing of extraction socket with and without suture after removal of impacted mandibular third molars-A Randomised clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| drchandansingh |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandan Singh |
| Designation |
MDS Student |
| Affiliation |
Rungta College of Dental Sciences and Research Bhilai CG |
| Address |
HN 22 block A Govt dental college campus Rajbandha maidan Raipur CG Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG Raipur CHHATTISGARH 492001 India |
| Phone |
9907276363 |
| Fax |
|
| Email |
drchandansingh1307@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sruthi Rao |
| Designation |
Professor & HOD |
| Affiliation |
Rungta College of Dental Sciences and Research Bhilai CG |
| Address |
Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG
Durg CHHATTISGARH 490024 India |
| Phone |
8518882523 |
| Fax |
|
| Email |
shrusurg@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sruthi Rao |
| Designation |
Professor & HOD |
| Affiliation |
Rungta College of Dental Sciences and Research Bhilai CG |
| Address |
Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG
CHHATTISGARH 490024 India |
| Phone |
8518882523 |
| Fax |
|
| Email |
shrusurg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rungta college of dental sciences and research kohka Bhilai CG India 490024 |
|
|
Primary Sponsor
|
| Name |
Dr Chandan Singh |
| Address |
Rungta college of dental sciences and research kohka Bhilai CG india 490024 |
| 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 Chandan Singh |
Rungta college of dental sciences and research Bhilai CG |
room no 3 Department of oral and maxillofacial surgery Durg CHHATTISGARH |
9907276363
drchandansingh1307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Rungta college of dental sciences and research Bhilai CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K01||Embedded and impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
with suture |
Third molar surgical extraction with suture placement placement conventional triangular incision will be placed mucoperiosteal flap will be elevated buccal and distal guttering will be done tooth sectioning will be done if needed tooth will be elevated and suture will be placed |
| Intervention |
without suture |
Third molar surgical extraction without silk suture placement conventional triangular incision will be placed mucoperiosteal flap will be elevated buccal and distal guttering will be done tooth sectioning will be done if needed tooth will be elevated and suture will not be placed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Class I patients.
2. Patients between the ages of 18 – 40 years.
3. Patients with impacted mandibular third molar.
4. Asymptomatic at the time of surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patients allergic to local anesthetics
2. Pregnant or lactating mother
3. Patients with systemic diseases.
4. Presence of acute infections / swelling / pathology in oral cavity at the time of surgery.
5. Patients taking medication that could interfere with healing after surgery.
6. Intellectually and developmentally disabled patients.
7. Patients with poor oral hygiene or periodontally compromised patients.
8. Smokers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing |
post op day 1,2,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain,trismus,facial swelling |
post op day 1,2,7 |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
10/10/2024 |
| 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="6" 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
|
NEED FOR THE STUDY: The removal of an impacted third molar is the most common surgical procedure performed by oral surgeons 1. These teeth generally erupt between the ages of 17 and 21 years. It has also been reported that the third molar eruption varies with races, such as in Nigeria mandibular third molars may erupt as early as 14 years and in Europe it may erupt up to the age of 26 years. Factors such as the nature of the diet that may lead to attrition, reduced mesiodistal crown diameter, degree of use of the masticatory apparatus and genetic inheritance also affect the timing of third molar eruption2. Impacted tooth is defined as a tooth that is prevented from erupting into position within the expected time due to a physical barrier within the path of eruption . 3rd molar impactions are associated with several acute or chronic pathological changes, such as pain, infection, caries, periodontal disease, root resorption, bone loss, cyst formation, and benign tumors, justifying its removal. Pain, swelling, decreased mouth opening and temporary inability to work are the generally accepted inevitable postoperative consequences following surgical extraction. This is further associated with a significant deterioration in oral health related quality of life in the immediate postoperative period and an increase in the total expenditure for removal of third molars 3. One of the factors most closely linked to the intensity of post-operative pain and swelling is the type of healing of the surgical wound. In secondary healing, the socket remains in communication with the oral cavity; in primary healing, the socket is covered and sealed hermetically by a mucosa flap4. Damage to the capillary vessels and the release of inflammatory cytokines as a result of the trauma lead to increased permeability of vessels, which results in accumulation of serosanguinous fluid and exudates.5 Conflicting opinions have been expressed in the literature concerning these two types of healing. Some authors are in favour of closed healing, whereas other authors report that primary healing frequently causes greater pain and swelling than secondary healing. Other authors are of the opinion that postoperative progress does not differ in the two types of healing 4. The present study is intended to compare the pain , swelling , trismus and healing of extraction socket with suture and without suture after removal of impacted mandibular third molar . |