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

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.