Evaluation of efficacy of n-butyl 2 cyanoacrylate in intra-oral soft tissue closure in alveoloplasty: Clinical split-mouth comparative study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Intra-operative ease of closure of the surgical site and efficient hemostasis with use of cyanoacrylate glue.
Study Overview
Brief Summary
This is a split-mouth comparative, clinical and prospective study of patients undergoing alveoloplasty reporting to the Department of Oral and Maxillofacial Surgery, SDS, KVV. Patients with bony spicules/protuberances indicated for alveoloplasty will be enrolled for the study.
All patients requiring alveoloplasty, fulfilling inclusion criteria and giving consent for the study will be included in study, after the approval of ethical committee. The participants will be analysed on the basis of bony spicules present on both sides of either maxilla or mandible. For this study, a split-mouth, comparative analysis will be done by the division of two operative sites; i.e. Site A (Control site) and Site B (Study site).
SITE A (Control site) will get treated with (closure with 3-0 silk suture) and
SITE B (Study site) will get treated with (closure with N-butyl 2 cyanoacrylate glue)
The right side of the arch will be taken as control site while the left will be study site.
Post-operatively, clinical assessment will be performed at immediate 3rd, 7th, 14th and 21st day post-operatively.
Parameters to be evaluated will include:
Intra-orally:
The time of intra-oral wound closure (in mins) will be divided by the length of incision margin taken (in mm) to evaluate the mean time taken to achieve intra-oral incision closure depending the length of incision.
Post-operatively:
The evaluation of pain assessment (by VAS Scale) and wound healing index score by Landry, Turnbull and Howley.
Clinical evaluation of the surgical sites will be done by blinded observer on 14th and 21st post-operative days.
All post-operative parameters will be recorded on 3rd, 7th, 14th and 21st follow-up days respectively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of both genders aged between 30-70 years.
- •Patients indicated for alveoloplasty.
- •Patients non-allergic to cyanoacrylates and silk.
- •Patients willing for participation in the study and give written informed consent.
- •Patients indicated for alveoloplasty in both sides of either maxilla or mandible.
Exclusion Criteria
- •Patients who are allergic to cyanoacrylates and silk.
- •Patients out of the age range of 30-70 years.
- •Patients with compromised systemic health.
- •uncontrolled diabetes, severe cardiovascular diseases or immunocompromised patients
- •Patients on steroid therapy etc.
- •Inadequate bone volume, active infections, poor oral hygiene, haemorrhagic disorders, severe anxiety, psychological disorders.
- •Chronic smoking habit, pregnancy and recent radiation therapy.
Outcomes
Primary Outcomes
Intra-operative ease of closure of the surgical site and efficient hemostasis with use of cyanoacrylate glue.
Time Frame: Follow up: | Clinical assessment will be performed at immediate post-operatively, 3rd, 7th, 14th and 21st days post-operatively.
Secondary Outcomes
- Effective wound healing, lesser pain & no suture tracks evident on operative site, post-operatively,(can be used as relevantly as conventional method of wound closure, that is, suturing)
Investigators
Simran Arawattigi
Krishna Vishwa Vidyapeeth, Karad