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CTRI Number  CTRI/2024/10/074919 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of periotome tooth extraction technique on socket healing.  
Scientific Title of Study   Periotome As An Aid To Atraumatic Extraction In Orthodontic Mandibular Single Rooted Tooth: A Split-mouth 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 Shubham Kherde 
Designation  P.G. student 
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room no.2, Oral and maxillofacial surgery department, Chhattisgarh Dental College and Research Institute.

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9730409889  
Fax    
Email  shubhamkherde97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anshul Sharma 
Designation  Reader 
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room no.2, Oral and maxillofacial surgery department, Chhattisgarh Dental College and Research Institute.

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7587139040  
Fax    
Email  anshul.sharma63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Anshul Sharma 
Designation  Reader 
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Room No.2, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute.

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7587139040  
Fax    
Email  anshul.sharma63@gmail.com  
 
Source of Monetary or Material Support  
Room No. 2, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute, Rajnandgaon, Chhattisgarh-491441. 
 
Primary Sponsor  
Name  DR SHUBHAM KHERDE 
Address  Room No. 2, Oral And Maxillofacial Surgery Department, Chhattisgarh Dental College And Research Institute, Rajnandgaon, Chhattisgarh-491441. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubham Kherde  Chhattisgarh Dental College and Research Institute.  Room no.2, Oral and maxillofacial surgery department, Chhattisgarh Dental College and Research dental college.
Rajnandgaon
CHHATTISGARH 		 9730409889

shubhamkherde97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Chhattisgarh Dental College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Periosteal Elevator And Tooth Extraction Forceps.  A Conventional Periosteal Elevator Will Be Use To Luxate The Tooth Followed By Extraction Forceps To Extract The Tooth. Duration- once. 
Intervention  Periotome Instrument  Periotome With Blade Attachment Was Held In Modified Pen Grasp And Inserted At 20 Degrees To The Long Axis Of Tooth Into The Gingival Sulcus. It Was Used To Sever The Crevical Gingival Attachment Fibres First And Then Proceed Several Milli-metres Into Periodontal Ligament Space And Inclined First Mesially And Then Distally Tangential To Root Surface. Once The Access Was Obtained , The Instrument Was Gradually Advanced Into The Pdl Space Repeating The Same Motion Until Two-thirds Of The Of The Distance Towards The Apex Of Root Reached. Then Tooth Was Extracted Using Extraction Forceps Exerting Rotational Force In A Coronal Direction. Duration-once  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Bilateral Orthodontic Mandibular Single Rooted Tooth Extraction.

2. 18-30 Years Age Group.

3. American Society Of Anesthesiologists (Asa) Type I. A Normal Healthy Patient, Non-smoking, No Or Minimal Alcohol Use, (No Acute Or Chronic Disease).

4. Patients Willing For Extraction And Participating In The Study. 
 
ExclusionCriteria 
Details  1. Dilacerated , Multi-rooted, Endodontically Compromised Tooth.

2.Patients Who Were Taking Drugs Which Interfere With Pain Response.

3. Allergy To Ketorolac Tromethamine, Lignocaine And Adrenaline.

4. Periodontally Compromised Tooth / Patients Suffering From Localized/Generalized Periodontitis.

5. Pregnant And Lactating Females And Patients On Oral Contraceptives.

6. Medically Compromised Patients.

7. Tobacco Chewers And Smokers.

8. Patients Requiring Repeated Injection Of Local Anesthetics.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Pain Scale
:1-10

Gingival Laceration:
0.5 mm - abrasion
5-10mm - partial
above 10mm - complete depth
Torn gingiva 		 1st day, 3rd day and 7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Age, Gender  Age, Gender 
post operative pain on 1st , 3rd,7th day   visual pain analogue scale
1-10 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/10/2024 
Date of Study Completion (India) 05/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/08/2025 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   BRIEF RESUME OF INTENDED STUDY

NEED OF THE STUDY -The specialty of maxillofacial surgery has made tremendous strides in the past few decades encompassing such diverse fields as craniofacial surgery, micro-vascular reconstruction, etc. But the most commonly performed procedure by maxillofacial surgeons in many countries continues to be exodontia, comprising non-surgical routine tooth extractions as well as impacted tooth removal. Improvements in local anesthetics as well as its delivery armamentarium have resulted in painless extractions but the fear of post extraction pain deters many patients from undergoing this procedure. Soft tissue trauma is one of the reasons for post extraction pain and various techniques have been tried to reduce this component’s contribution. With the advent of implantology, atraumatic extraction has come into vogue again and proponents of periotome have claimed that it not only reduces soft tissue injury but also aids in salvaging the bony integrity of the socket as well.

AIM & OBJECTIVES: 

AIM -The aim of this study is compare and to evaluate the efficacy of periotome in orthodontic mandibular single rooted nonsurgical tooth extractions with conventional mandibular single rooted nonsurgical tooth extractions. 

OBJECTIVE -The objective of this study is to assess the efficacy of periotome in orthodontic mandibular single rooted nonsurgical tooth extractions with orthodontic mandibular conventional single rooted nonsurgical tooth extractions with regards to following parameters:
- Pain was assessed using visual analogue scale all throughout 7 days postoperatively. 
- Gingival laceration. 
- duration of procedure. 
- number and frequency of analgesics consumed and 
- complications (if present) were also noted

MATERIALS AND METHOD MATERIALS 
A split mouth study will be performed in 50 patients. All patients will undergo the non-surgical extractions of orthodontic bilateral mandibular single rooted teeth. Before enrolment, the objectives, implications and possible complications of this clinical trial were explained to all the patients and informed consent was obtained. The patients did not receive any financial compensation for participating in the study. Following armamentarium and materials will be required for this study – 
- Periotome extraction kit. 
- Orthopantomogram. 
- 2% lignocaine hydrochloride with 1:80,000 adrenaline (LIGNOX 2%, INDOCO REMEDIES LTD). 
- Disposable 3 ml syringe and needle. 
- Conventional extraction forceps / kit. 

METHODOLOGY: 

TYPE OF STUDY Prospective interventional Split- mouth study. 

SOURCE OF THE DATA 
The study will be conducted in the Department of Oral and Maxillofacial Surgery at Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh 491441. 

SAMPLING TECHNIQUE Non-randomized - Convenience sampling technique. 

SAMPLE SIZE CALCULATION 
The sample size calculation was done using G*Power 3.1.9.2 software. Parameters used in calculation: Effect size d = 0.59 α err prob = 0.05 Power (1-β err prob) = 0.90 Allocation ratio N2/N1 = 1 Non-centrality parameter δ = 2.9500000 Critical t = 1.6605512 Df = 98 Considering 5% alpha error and 90% power for the study, the total sample size for this study is 100 

METHOD OF COLLECTION OF DATA 
The study will consist of 50 patients reporting to the Department of Oral and Maxillofacial Surgery at Chhattisgarh Dental College and Research Institute who will be undergone for orthodontic bilateral mandibular single rooted Non-surgical extraction. 

Group A(control group): orthodontic mandibular single rooted Non-surgical extraction with conventional periosteal elevator followed by extraction by conventional forceps. 

Group B(test group): orthodontic mandibular single rooted Non-surgical extraction with periotome kit followed by extraction by conventional forceps. The case selection will be done after obtaining detailed case history, clinical examination and radiographic assessment using orthopantomogram and intraoral periapical radiographs. Patients will be explained about the study and asked to sign an informed consent form. 

CRITERIA FOR SELECTION OF PATIENT INCLUSION CRITERIA 

- Bilateral orthodontic mandibular single rooted tooth extraction.
- 18-30 years of age group.
- American Society of Anesthesiologists (ASA) type I. A normal healthy patient, non-smoking, no or minimal alcohol use, (no acute or chronic disease). 
- Patients willing for extraction and participating in the study. 

EXCLUSION CRITERIA 
- Dilacerated , multi-rooted, endodontically compromised tooth. 
- patients who were taking drugs which interfere with pain response. 
- Allergy to ketorolac tromethamine, lignocaine and adrenaline. 
- Periodontally compromised tooth / patients suffering from localized/generalized periodontitis. 
- Pregnant and lactating females and patients on oral contraceptives. 
- Medically compromised patients. 
- Tobacco chewers and smokers. 
- Patients requiring repeated injection of local anesthetics. 

STUDY DESIGN 
In all patients a detailed case history will be taken to rule out any systemic conditions that contraindicate orthodontic mandibular single rooted non-surgical extraction and the use of local anesthesia with adrenaline. The patient will be explained about the study and will be required to sign a consent form showing their approval for the study. Group A: will consist of 50 samples who will undergone for orthodontic mandibular single rooted non-surgical extraction with conventional periosteal elevator followed by extraction by conventional forceps. Group B: will consist of 50 samples who will undergone for single rooted non-surgical extraction with periotome kit followed by extraction by conventional forceps. 

SURGICAL PROCEDURE 
Tooth extractions will be carried out aseptically under local anesthesia (2 % lignocaine with 1:80,000 adrenaline) and post extraction instructions Will be given to each patient. In the control group A, after clinical assessment of tooth to be extracted periosteal elevator will be used for reflecting the gingiva to expose the cemento-enamel junction and the extraction will be carried out using conventional forceps. In the test group B, after clinical assessment of tooth to be extracted periotome held in modified pen grasp and inserted at 20 degrees to the long axis of tooth into the gingival sulcus. It will be used to sever the cervical gingival attachment fibres first and then proceed several millimeters into periodontal ligament space and inclined first mesially and then distally tangential to root surface. Once the access obtained, the instrument will be gradually advanced into the PDL space repeating the same motion until two-thirds of the distance towards the apex of root will be reached. Then tooth will be extracted using extraction forceps exerting rotational force in a coronal direction. Ketorolac tromethamine 10 mg will be given immediately after completion of extraction and 1 Tab SOS later as analgesic. No other postoperative medication will be prescribed. Patients will be instructed not to seek any medical help elsewhere for postoperative problems, if any, but to report to our department. They will be followed-up for a minimum period of 1 week for evaluation of wound. 

- All patients will be treated by same surgeon. 
- All patients will undergo the standard procedure for single rooted non-surgical removal of tooth.
 
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