| CTRI Number |
CTRI/2024/05/067868 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the healing outcome with human amniotic membrane, hydroxyapatite graft and laser biostimulation in patients having periapical lesion. |
|
Scientific Title of Study
|
Comparative Analysis of Periapical Healing with Human Amniotic Membrane, Hydroxyapatite Graft and Laser Biostimulation in Peri Radicular Surgery Cases-A CBCT Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajat Shukla |
| Designation |
MDS(Postgraduate) |
| Affiliation |
ITS Dental College Hospital And Reasearch Centre, Greater Noida |
| Address |
Room no 7, Department of Conservative Dentistry and Endodontics, I.T.S Dental College Hospital And Reasearch Centre,
47 Knowlege Park III,
201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
7248367592 |
| Fax |
|
| Email |
shuklarajatat22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room no 7 Department of Conservative Dentistry and Endodontics, I.T.S Dental College, Greater Noida
47 Knowlege Park III,
Uttar Pradesh 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
09811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju kumari |
| Designation |
Professor |
| Affiliation |
I.T.S Dental College Hospital and Research Centre |
| Address |
Room no 7 Department of Conservative Dentistry and Endodontics, I.T.S Dental College, Greater Noida
47 Knowlege Park III,
Uttar Pradesh 201308
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
09811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no.7, Department of Conservative dentistry and Endodontics, I.T.S Dental College, Greater Noida, 47 Knowlege park III, Greater Noida, Gautam buddha Nagar, Uttar Pradesh, 201308 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital And Reseach Centre |
| Address |
Room no 7 Department of Conservative Dentistry and Endodontics, I.T.S Dental College, Greater Noida,47 Knowlege park III, Greater Noida, Gautam buddha Nagar, Uttar Pradesh, 201308
|
| 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 |
| Dr Rajat Shukla |
ITS Dental College Hospital And Reseach Centre |
Room no 7 Department of conservative dentistry and Endodontics
ITS Dental College and Research Centre
Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
7248367592
shuklarajatat22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental college hospital and research centre instititional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human amniotic membrane and Laser biostimulation on patient having periapical lesion. |
This group will evaluate the healing after placement of human amniotic membrane followed by laser biostimulation in 8 patients having periapical lesion not more than 10 mm diameter after periapical surgery, at 3 months, 6 months and 12 months interval using cbct. |
| Intervention |
Hydroxyapatite bone graft and Laser biostimulation on patients having periapical lesion. |
This group will evaluate the healing after placement of hydroxyapatite bone graft followed by laser biostimulation in 8 patients having periapical lesion not more than 10 mm diameter after periapical surgey, at 3 months, 6 months and 12 months interval using cbct. |
| Comparator Agent |
Laser biostimulation on patients having periapical lesion. |
This group will evaluate the healing after laser biostimulation in 8 patients having periapical lesion not more than 10 mm diameter after periapical surgery, at 3 months, 6 months and 12 months interval using cbct.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.18 to 40 years of age
2.Teeth with Periapical Radiolucency indicated for surgery.
3.Patient not on any medication affecting periapical healing. (Corticosteroids, chemotherapeutic agents, Anticoagulants, drugs which reduce osteoclastic activity.)
4.Noncontributory medical history (ASA I & II).
5.Single rooted anterior teeth with intact palatal/lingual bone.
6.Lesion size less than 10 mm.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant females
2.Patient with periodontally compromised teeth.
3.Patient having insufficient motivation to report back for follow ups.
5.Lesion size greater than 10 mm.
6.Vertical root fracture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare periapical healing after endodontic surgeries using Human Amniotic Membrane, hydroxyapatite graft and Laser Biostimulation using CBCT.
|
Periapical healing will be evaluated at the time interval of baseline,3 months, 6 months and 12 months interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out which group among human amniotic membrane, hydroxyapatite graft And laser biostimulation will give the best healing outcome after endodontic surgeries. |
At the baseline, 3 months, 6 months And 12 months interval. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
28/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study will be done to evaluate the healing after periapical surgery in the patients having periapical lesion not more than 10mm.The forthcoming in vivo study will be carried out within the department of conservative dentistry and endodontics at ITS dental college and research centre in greater Noida, uttarpradesh. A clinical diagnosis for the patient reporting to the department of conservative dentistry and endodontics will be made and 24 patients age18 to 40 years will be selected by the inclusion and exclusion criteria. Included patient will then be informed about the study and explained in detail about the procedure. A preoperative CBCT will be taken to assess the size of periapical radiolucency Patient will then be divided randomly to the following groups. Group1- 8 patients with periapical lesion, laser biostimulation will be done after peri apical surgery Group 2- 8 patients with periapical lesion, human amniotic membrane will be placed along with laser biostimulation after peri apical surgery. Group3- 8 patients with periapical lesion, hydroxyapatite bone graft will be placed along with laser biostimulation after peri apical surgery. Root canal treatment will be performed in relation to all the effected teeth. Under proper isolation, the root canals will be obturated using gutta percha and AH plus sealer prior to the surgery. A radiograph will be taken to assess the root canal treatment. Surgical intervention will be facilitated using a crevicular incision aided with a unilateral posterior release after thorough anesthesia will be attained using 2% lignocaine. The reflection of the full thickness mucoperiosteal flap, a bony window will be created through the cortical bone. This facilitated access to the cystic lining and the granulation tissue, which will be carefully curetted and will be sent for biopsy. Residual inflammatory connective tissue will be curetted, the root ends will be resected. Root end cavities will be prepared with low-speed bur and filled with MTA as a retrograde filling material. The surgical area will be thoroughly irrigated and isolated. The area will be packed with hydroxyapatite graft or human amniotic membrane (depending on the respective group) followed by laser biostimulation. Hemostasis will be achieved and the mucoperiosteal flap will be sutured back to its original anatomical position with 4-0 silk sutures. Necessary post-operative instructions will be advised, and the patient will be prescribed antibiotics and analgesics. Proper plaque control will be emphasized with the use of 0.2% chlorhexidine gluconate mouthwash twice daily for at least 2 weeks. A post-surgical visit after one week to check any adverse effects or any allergic reactions to the material. VAS scale will be used to score the discomfort immediate post-operatively and at the recall visit after a week. The patient will be recalled at 3, 6, and 12-months interval. Radiographs will be taken to assess the bone healing in the periapical region.
|