| CTRI Number |
CTRI/2026/02/104120 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of three methods of bleeding control after milk tooth removal in children aged 5-12 years |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Effectiveness of Two Therapeutic Agents for Local Hemostasis after Primary Molar Extraction in Children Aged 5-12 Years: A Prospective Randomized Control 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 Titus Shajan |
| Designation |
Post Graduate Student |
| Affiliation |
|
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 7
Second Floor
Vydehi Institute of Dental Sciences and Research Centre
82 Nallurahalli Main Rd near BMTC 18th Depot Vijayanagar Nallurhalli Whitefield Bengaluru Karnataka
Bangalore KARNATAKA 560066 India |
| Phone |
8111931191 |
| Fax |
|
| Email |
titusshajan3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Namratha T |
| Designation |
Reader |
| Affiliation |
|
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 7
Second Floor
Vydehi Institute of Dental Sciences and Research Centre
82 Nallurahalli Main Rd near BMTC 18th Depot Vijayanagar Nallurhalli Whitefield Bengaluru Karnataka
Bangalore KARNATAKA 560066 India |
| Phone |
9704058513 |
| Fax |
|
| Email |
namratha.tharay9488@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jaya Naidu |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Department of Pediatric and Preventive Dentistry
Vydehi Institute of Dental Sciences and Research Centre
82 Nallurahalli Main Rd near BMTC 18th Depot Vijayanagar Nallurhalli Whitefield Bengaluru Karnataka
Bangalore KARNATAKA 560066 India |
| Phone |
9845402319 |
| Fax |
|
| Email |
vids_jaya383@vimsmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Titus Shajan |
| Address |
Department of Pediatric and Preventive Dentistry
Room Number 7
Vydehi Institute of Dental Sciences and Research Centre
82 Nallurahalli Main Rd near BMTC 18th Depot Vijayanagar Nallurhalli Whitefield Bengaluru Karnataka |
| 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 Titus Shajan |
Vydehi Institute of Dental Sciences and Research Centre |
Department of Pediatric and Preventive dentistry
Room Number 7
Vydehi Institute of Dental Sciences and Research Centre EPIP Area
Whitefield Bangalore KARNATAKA |
8111931191
titusshajan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Feracrylum |
After extraction the socket will be irrigated with two and half ml of one percent feracrylum of Themis Medicare Ltd followed by the placement of four inches dampened sterile gauge soaked in one percent feracrylum as pressure pack for thirty minutes |
| Comparator Agent |
pressure pack |
After extraction the socket will be placed with 4 inches dampened sterile gauge soaked in sterile water as pressure pack for thirty minutes |
| Intervention |
Vitamin C and Zinc |
An active solution of Vitamin C and Zinc will be produced before extraction by dissolving one chewable tablet that contains forty mg of vitamin C and 10 mg of Zinc of Well C Kids by Goa Nutritions of GNL company in Gujarat in twenty ml of sterile water and stirring until the tablet is completely disintegrated to form a fine particular suspension
Immediately after extraction a 4 inches gauze pack soaked and dampened in the solution will be placed on the socket for thirty minutes |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 to 12 years irrespective of the gender requiring at least two indicated primary molar tooth extractions and fitting to modified Fanning’s Root Resorption Stages
Children belonging to the American Society of Anesthesiologists Class one status
Children whose parents or legal guardians are willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Children belonging to American Society of Anesthesiologists Class other than one
Children with primary molars with modified Fanning Root Resorption Stages Res of two third and three fourth as well as complete
Children with severe acute dental pain and infections
Children with allergy or hypersensitivity to any of the products that are used in the study
Children whose parents or legal guardians are unwilling to participate in the study
Children with any other extractions than simple extractions.
|
|
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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 primary outcome of the study is to assess the influence of two different agents used on the bleeding control postoperatively as compared with the traditional pressure pack |
Assessment of Bleeding
The postoperative bleeding will be assessed with the help of the scale of postoperative bleeding by Mattox in the year 2021 at 2 and 10 and 15 minutes and the gradings will be noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of two different agents on soft tissue healing after primary molar extraction in healthy children aged 5 to 12 years with traditional pressure pack |
The wound healing at the extraction site will be graded and noted using Landry RG Turnbull RS and Howley T analysis on the seventh postoperative day |
| To assess the taste perception of different hemostatic packs assessed for reducing bleeding after primary molar extraction in healthy children aged 5 to 12 years with traditional pressure pack |
The postoperative taste perception after 30 minutes of the placement of hemostatic agents will be evaluated subjectively with the help of a validated TASTY taste perception scale developed by Jennifer A et al in 2020 |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
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 4 |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="1" Months="0" 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
|
| A total of 33 children with three extraction sites who meet the inclusion criteria will be included in the study after obtaining written informed consent from the parents/guardians and verbal assent from the children. The extraction site will be allocated into one of the three groups by simple randomization using computer generated randomized sequence A centralized assignment will be used as an allocation concealment mechanism to prevent selection bias. Once the allotment is done, the extraction will be performed under aseptic conditions. For maxillary tooth extractions, local infiltrations with a short twenty mm thirty gauge needle both buccally and palatally will be administered, whereas for mandibular primary molar extractions, inferior alveolar nerve block and a lingual nerve block with a length of thirty two mm and twenty seven gauge will be given using two percent lignocaine with one in eighty thousand dilution of adrenaline. Procedure of Extraction First a Periosteal elevator will be used to free the attached gingiva from the cervix of the tooth labially and lingually followed by slight luxation of the tooth with the same instrument. Then a firm apical pressure will be applied with the respective arch-specific or side-specific forceps. Initial luxation movement will be given to the buccal side followed by holding the pressure momentarily permitting buccal alveolar plate expansion. Then, the luxating force is returned to lingually or palatally. And held such that the pressure permits lingual alveolar plate expansion. Alternate the buccal and lingual or palatally movements to further expand the cortical plate. When there is adequate freedom of movement, deliver the tooth to the buccal side, exercising slow, firm, continuous pressure. Mold the labial and palatal cortical plates into normal conformity with finger pressure.After the extraction of primary molars, a folded sterile gauze soaked with one of the two study hemostatic agents will be placed over the wound. The current study consists of two groups of two hemostatic agents assessed for their hemostatic action and soft tissue healing capacity. The groups are as follows Group A Standard Group After extraction, the socket will be irrigated with 2.5 ml of 1 percent feracrylum (Sepgard Solution 100 ml, Themis Medicare Ltd. Mumbai, India) followed by the placement of 4 inches dampened sterile gauge soaked in 1 percent Feracylum as pressure pack for 30 minutes. Group B Intervention Group An active solution of Vitamin C & Zinc will be produced before extraction by dissolving one chewable tablet that contains 40 mg of vitamin C & 10 mg of Zinc of Well C Kids, Goa Nutritions, GNL company, Gujarat, India in 20 ml of sterile water and stirring until the tablet is completely disintegrated to form a fine particular suspension. Immediately after extraction, a 4 inches gauze pack soaked and dampened in the solution will be placed on the socket for 30 min. Group C Control Group After extraction, the socket will be placed with 4 inches dampened sterile gauge soaked in sterile water as pressure pack for 30 minutes. Parameters Assessed Assessment of Bleeding | The postoperative bleeding will be assessed with the help of the scale of postoperative bleeding by Mattoxof 2021 at 2, 10 and 15 minutes, respectively, and the gradings will be noted. Assessment of soft tissue healing The wound healing at the extraction site will be graded and noted using Landry RG, Turnbull RS, and Howley T analysis on the seventh postoperative day. |
Assessment of Taste Perception The postoperative taste perception after 30 minutes of the placement of hemostatic agents will be evaluated subjectively with the help of a validated TASTY taste perception scale, developed by Jennifer A et al in 2020 The child will be shown the pictorial representation as shown below and inquired to point out at one figure stating how the taste is after the placement of the respective therapeutic pressure packs.
| As the present study adapts a split mouth design, a period of 7 days will be given as washout period to wean off the influence of one intervention on the other. On the 7th day, the other primary tooth will be extracted with the application of another hemostatic agent and also on the 14th day. Hence, with the follow-up period, the current study requires a total of 21 days for one subject. Therefore, the primary outcome of the study is to assess the influence of two different agents used on the bleeding control postoperatively as compared with the traditional pressure pack. The secondary outcome is to evaluate the influence of these hemostatic agents on soft tissue healing and taste perception with the traditional pressure pack in children. | | |