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临床试验/CTRI/2025/12/098451
CTRI/2025/12/098451招募中不适用

EVALUATION OF EFFECT OF 0.75% BORIC ACID GEL ON IMPLANT STABILITY, CRESTAL BONE LEVEL AND OSTEOCALCIN LEVELS AROUND DENTAL IMPLANTS.

Bharati Vidyapeeth Dental College and Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年12月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12
试验地点
2

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate the effect of 0.75% boric acid gel on peri-implant healing by assessing three key outcome parameters: implant stability, crestal bone level, and osteocalcin concentration around dental implants. Boric acid, known for its anti-inflammatory and osteogenic properties, may enhance osseointegration and improve peri-implant tissue health. Eligible partially edentulous patients requiring implant placement will be randomly allocated into a test group (boric acid gel application) and a control group (no gel application).

Standardized implant placement will be performed using an endosseous implant system.   implant stability will be measured using resonance frequency analysis (Osstell ISQ) at baseline, 3, 6, and 9 months.  will be assessed using CBCT at baseline, 3, 6, and 9 months. Peripheral implant crevicular fluid (PICF) will be collected at scheduled visits to quantify osteocalcin using ELISA.

The study aims to determine whether the adjunctive application of boric acid gel improves implant stability, crestal bone loss, and osteocalcin level for bone formation.  Findings may support the use of boric-acid–based biomaterials as cost-effective adjuncts for improving implant success and long-term peri-implant health.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Day(s) 至 99.00 Day(s)(—)
性别
All

入选标准

  • Patients of age 18 years and above Signed informed consent given by the patient.
  • Patients with missing tooth on maxilla/mandible Have at least one tooth, both single or multi-rooted, indicated to extraction due to crack, fracture, or perforation and the possibility of placement of a dental implant Adequate bone dimensions for implant placement without the need for guided bone regeneration procedures Post extraction alveolar sockets with at least three remaining walls Good general health, which allows for dental implant surgery.

排除标准

  • Active orthodontic treatment Previous periodontal surgery Systemic diseases like DM Type – 1, Hypertension, Hypothyroidism, etc.
  • Use of anti – coagulant therapy Use of any drugs that might lead to gingival enlargement History of radiation therapy in head and neck region.

研究者

发起方
Bharati Vidyapeeth Dental College and Hospital
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pallavi Sitaram Kamble

Bharati Vidyapeeth Dental College and Hospital

研究点 (2)

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