assessment of the effects of physics forceps versus the conventional forceps in the extraction of teeth - a randomised controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Before beginningthe procedure a occlusal template will be fabricated using the modelling wax byplacing it over the tooth that is supposed to be extracted and the adjacenttooth in order for the references and the Williams graduated probe is used tocalculate the distance between the lower border of the template to the borderof the gingiva giving pre extraction gingiva and same probe is placed on thebone 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 andrecorded as pre surgical measurements.
Extractions weredone following the standard aseptic surgical protocol. Local anaesthesiacontaining 2% lignocaine hydrochloride with 1:2,00,000 adrenaline was used togive regional nerve block along with local infiltrations in every extractionusing 26 gauge disposable syringe.
Mucoperiosteal flaps reflection usingperiosteal elevator was only done in extractions which were to be carried outusing conventional forceps. Elevators were not used for luxation of tooth to beextracted. Tooth specific forceps were used for extraction of specific tooth inconventional forceps system. The beaks of conventional forceps were placed atthe cement-enamel junction of particular tooth and it was extracted giving thetooth specific movements. The beaks of physics forceps were placed on lingual/palatal aspect of tooth at or below cement-enamel junction and bumper wasplaced on buccal alveolar ridge at mucogingival junction and constantcontrolled traction forces was given until tooth was displaced out of thesocket.
Time taken forthe extraction was considered from the point of application of the forcepsbeaks on the tooth to the delivery of the tooth out of the socket, measuredusing stopwatch and recorded in seconds. Compressions of the sockets was notdone following the extractions extracted tooth was clinically examined for theroot fracture and adherence of buccal plate to the root and recorded.
Following theextraction the template was again placed over the teeth and distance betweenthe marginal gingiva and lower edge of template was measured which showed postextraction gingival level. Post extraction bone levels was measured by placingthe probe into extracted socket and feeling the bone margins, distance wasmeasured from the edge of the template.
The mean value of pre extraction and postextraction level at three points was then calculated and the difference betweenthese two values suggested the amount of marginal gingiva and bone loss.
The extractionwas 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: limitedsuccess with root tip fracture – extraction involving root tip fracture
Score 3: limitedsuccess with root fracture – extraction involving root one or more rootfracture or crown fracture.
Score 2: limitedsuccess with osteotomy – fracture free extraction and partial osteotomy in casedivergent roots and thick cortical bone was present
Score 1: failureto extract
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 1st day, 3rd day ad 7th day
次要结局
- 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)
