The effect of intra-socket Vitamin E placement in reducing dry socket occurance and postoperative pain in multiple mandibular extractions: A split-mouth triple blinded randomized control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Post operative pain evaluation is done using visual analog scale and
Study Overview
Brief Summary
Vitamin E is a lipid soluble basic vitamin and consists of two subgroups: tocopherol and tocotrienol. Vitamin E is the collective name for a group of fat soluble compounds with distinctive antioxidant activities. Naturally occurring vitamin E exists in eight chemical forms (alpha, beta , gamma , and delta tocopherol that have varying levels of biological activity. Dry socket (alveolar osteitis) is the presence of postoperative pain in and around the extraction site that worsens 1 to 3 days after the extraction followed by a partially or completely disintegrated blood clot within alveolar socket with or without halitosis.The primary aim of this cinical trial is to evaluate the effectiveness of intra socket vitamin E in reducing post operative pain and incidence of dry socket in bilateral mandibular extractions.The present split-mouth study is a prospective triple blinded clinical trial of sample size of 59 patients. We will be selecting patients reporting to Oral and Maxillofacial Surgery department requiring with bilateral mandibular extractions. One side of the extractions in mandible will be randomly assigned to the test group , where a piece of gel foam will be cut into 1 cm2 and soaked in Vitamin E 400 IU soft gels squeezed out and packed whereas contralateral socket served as the control group will be receiving a placebo. The placebo will be a 1 cm2 gel form soaked in saline and placed in the control group. Patient will be recalled on 3rd, 7th, and 14th day for evaluation of post operative healing and pain, incidence of dry socket.
Post operative pain evaluation is done using visual analog scale and overall healing is evaluated using Laundry et al.
The assessment was done for the presence or absence of signs and symptoms of dry socket including halitosis, foul taste, socket devoid of clot with exposed bone that may be filled with food debris, edema of the surrounding gingiva, and regional lymphadenitis.
Case - Vitamin E soaked gel form placed on one side of mandible
Control - Placebo using Saline soaked gel form placed on other side of mandible
Blinding
-
Patient
-
Operator
-
Accessor
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Males and females aging 20 to
- •(to ensure that none of the post-menopausal since oestrogen and progesterone are important variables of dry socket) Patients with need of bilateral mandibular teeth extractions.
- •Complaince with all requirements in the study and signing the informed consen.
Exclusion Criteria
- •Patients with systemic diseases that may affect the outcomes of the study such as uncontrolled diabetes, hyperthyroidism , hyperparathyroidism, paget’s disease also diseases affecting bone healing , includes osteoporosis ,rickets ,and osteomalacia .
- •Patients on chronic medications affecting the periodontal status such as anticonvulsant , calcium channel blockers ,immunosuppressive , anti-inflammatory medications.
- •Pathological lesions at the site of impaction.
- •Patients with history of smoking , alcohol consumption, lactating mothers.
- •Patients currently on radiotherapy and or chemotherapy.
Outcomes
Primary Outcomes
Post operative pain evaluation is done using visual analog scale and
Time Frame: 3rd , 7th , 14th post operative day
overall healing is evaluated using Laundry et al.
Time Frame: 3rd , 7th , 14th post operative day
The assessment was done for the presence or absence of signs and symptoms of dry socket including halitosis, foul taste, socket devoid of clot with exposed bone that may be filled with food debris, edema of the surrounding gingiva, and regional lymphadenitis.
Time Frame: 3rd , 7th , 14th post operative day
Secondary Outcomes
- Symptomatic relief and reduced rate of post operative complication(3rd, 7th , 14th post operative day)
Investigators
ANAMIKA K S
Department of Oral and Maxillofacial Surgery