| 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
|
|
|
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
|
|
|
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.
|
|
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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 |