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CTRI Number  CTRI/2023/05/052833 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 17/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ASSESSMENT OF THE BENEFICIAL EFFECTS OF PHYSICS FORCEPS OVER THE CONVENTIONAL FORCEPS IN THE EXTRACTION OF TEETH  
Scientific Title of Study   assessment of the effects of physics forceps versus the conventional forceps in the extraction of teeth - a randomised controlled study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ritesh Kumar Singh  
Designation  POSTGRADUATE  
Affiliation  Manipal College of Dental Sciences, Managalore  
Address  department of oral and maxillofacial surgery,room no. 2, ground floor, ligh house hill road campus, manipal college of dental sciences
mnaipla college of dental sciences, ligh house hill road, hampankatte, managalore
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9113998020  
Fax    
Email  dr.riteshsingh1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ARVIND R 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Manipal College of Dental Sciences, Mangalore  
Address  Department of oral and maxillofacial surgery, room no. 2, ground floor, light house hill road campus, manipal college of dental sciences
Manipal college of dental sciences, light house hill road, hampankatte, mangalore
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9845794666  
Fax    
Email  arvind.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DR ARVIND R 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Manipal College of Dental Sciences, Mangalore  
Address  Department of oral and maxillofacial surgery, room no. 2, ground floor, light house hill road campus, manipal college of dental sciences
Manipal college of dental sciences, light house hill road, hampankatte, mangalore
Shimoga
KARNATAKA
575001
India 
Phone  9845794666  
Fax    
Email  arvind.r@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Mangalore  
 
Primary Sponsor  
Name  Manipal College of Dental Sciences  
Address  light house hill road, mangalore  
Type of Sponsor  Research institution and hospital 
 
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 RITESH KUMAR SINGH   manipal college of dental sciences, mangalore  room no. 2, ground floor ,department of oral and maxillofacial surgery, MCODS, mangalore
Dakshina Kannada
KARNATAKA 
9113998020

dr.riteshsingh1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional forceps   the conventional forceps will be used after raising the mucoperi-osteal flap to hold the tooth at cemento-enamel junction to perform the extraction  
Intervention  physics forceps   the physics forceps will be used without raising the mucoperi-osteal flaps, the tooth will be held in the beaks at cemento-enamel junction and will be extracted .time taken for the extraction will be calculated from the time of holding the tooth till the time tooth is extracted from the socket. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects who understand and are willing to follow the study procedure.
2.Subjects requiring the intra-alveolar extraction of the anterior, premolars or molars in maxillary or mandibular arches.
3.Subjects who are in good physical health with no clinically significant or relevant medical history.
4.Subjects in the age group of 15-65 years.
5.No active diseases with good oral health and hygiene.
 
 
ExclusionCriteria 
Details  1.Subjects with the habit of smoking, tobacco or alcohol use and exposure will be ascertained.
2.Subjects with uncontrolled diabetes or any other metabolic disorder/ immunocompromised
3.Subjects undergoing chemotherapy or radiotherapy and are on immunosuppressant drugs.
4.Female subjects who are pregnant or lactating mother.
5.Female subjects taking oral contraceptives
6.Subjects who are not available/ not willing for follow-up procedures.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
the outcome will be the physics forceps are comparatively better in preserving the soft tissue and the amount of bone loss when compared with the conventional forceps, with reduced pain and post operative complications.  1st day, 3rd day ad 7th day  
 
Secondary Outcome  
Outcome  TimePoints 
the secondary outcome will be assessed in order for the ease to perform the extraction, the efficacy of the forceps to perform the extraction or any kund of complicatio while doing the procedure   1st day  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/06/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Before beginning the procedure a occlusal template will be fabricated using the modelling wax by placing it over the tooth that is supposed to be extracted and the adjacent tooth in order for the references and the Williams graduated probe is used to calculate the distance between the lower border of the template to the border of the gingiva giving pre extraction gingiva and same probe is placed on the bone tip by a deep prick in order to measure the pre extraction bone height. All the measurements are done at 3 different sites i.e mesio-buccal, disto-buccal and mid-buccal region and the mean of the data is obtained and recorded as pre surgical measurements.

 

Extractions were done following the standard aseptic surgical protocol. Local anaesthesia containing 2% lignocaine hydrochloride with 1:2,00,000 adrenaline was used to give regional nerve block along with local infiltrations in every extraction using 26 gauge disposable syringe.

 

 Mucoperiosteal flaps reflection using periosteal elevator was only done in extractions which were to be carried out using conventional forceps. Elevators were not used for luxation of tooth to be extracted. Tooth specific forceps were used for extraction of specific tooth in conventional forceps system. The beaks of conventional forceps were placed at the cement-enamel junction of particular tooth and it was extracted giving the tooth specific movements. The beaks of physics forceps were placed on lingual/ palatal aspect of tooth at or below cement-enamel junction and bumper was placed on buccal alveolar ridge at mucogingival junction and constant controlled traction forces was given until tooth was displaced out of the socket.

 

Time taken for the extraction was considered from the point of application of the forceps beaks on the tooth to the delivery of the tooth out of the socket, measured using stopwatch and recorded in seconds. Compressions of the sockets was not done following the extractions extracted tooth was clinically examined for the root fracture and adherence of buccal plate to the root and recorded.

 

Following the extraction the template was again placed over the teeth and distance between the marginal gingiva and lower edge of template was measured which showed post extraction gingival level. Post extraction bone levels was measured by placing the probe into extracted socket and feeling the bone margins, distance was measured from the edge of the template.

 

 The mean value of pre extraction and post extraction level at three points was then calculated and the difference between these two values suggested the amount of marginal gingiva and bone loss.

 

The extraction was given success score based on the criteria given by Choi. Et al 12

Score 5: complete success – extraction without crown and root fracture

Score 4: limited success with root tip fracture – extraction involving root tip fracture

Score 3: limited success with root fracture – extraction involving root one or more root fracture or crown fracture.

Score 2: limited success with osteotomy – fracture free extraction and partial osteotomy in case divergent roots and thick cortical bone was present

Score 1: failure to extract

 
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