Efficacy of Hyaluronic Acid Gel and Photobiomodulation Therapy on Wound Healing After Surgical Gingivectomy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Landry's healing index
研究概览
简要总结
This study consists of random patient selection and allocating them in 3 different groups. After being fit to be included according to the protocol's criteria and signing an informed consent, patients will be distributed after performing a dental surgery known as gingivectomy. Gingivectomy has been classified as the gold standard treatment option for the control of gingival enlargement. Wound recovery after gingivectomy and gingivoplasty occurs by secondary intention healing, thus post-surgical wounds can be strongly associated with discomfort, pain and delayed healing. For that reason, the first group will consist of 13 patients who will be exposed to hyaluronic acid gel or gingigel and photobiomodulation therapy to see if there is significant results in the post-operative healing phase. The second group will also consist of 13 patients who will undergo only photobiomodulation therapy. While the third group will have no clinical supportive care besides follow-up and analgesics upon request.
All the values will be determined by using scores such as Visual analogue scale for pain, Landry's index for healing assessment and oral health quality of life, which consists of 14 questions to asses the enhancement of everyday problems affected by dental situations.
Each case will be followed-up for 3 months post-operative.
详细描述
The study group consisted of thirty-nine surgical gingivectomy wound sites on patients presenting with gingival hypertrophy on maxillary or mandibular anterior region. Groups will be randomly and equally divided into three groups, Group-A (Test Group 1): Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) at (940 nm, 0.21 W) with a fiber tip diameter of 400μm for 30 seconds, then covered with HA Gel. Group-B (Test Group 2): Surgical sites will be irradiated with diode laser only at (940 nm, 0.21 W). Group-C (Control Group): No post-surgical therapy will be performed. Wound healing was assessed by implementing Landry, Turnbull and Howley Healing index, while pain perception was objectively evaluated by the patients using the visual analog scale (VAS). To further evaluate the patient's quality of life, Oral Health Impact Profile (OHIP-14) records will be obtained before and after gingivectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient health ASA I, II
- •Average age from 18 to 40 years
- •Both genders
- •Chronic inflammatory gingival enlargement
- •Adequate amount of keratinized tissue.
- •Well educated patients as post-operative instructions need to be followed precisely.
排除标准
- •Bad oral hygiene
- •Allergy to Hyaluronic acid or cosmetic fillers containing H.A
- •Any patient under oral contraceptives or immunosuppressive drugs
- •Patients undergoing radiotherapy or chemotherapy
- •Pregnant or lactating mothers
- •Mentally disturbed patients
- •Excessive gag reflex
- •Patients who refuse to sign informed consent.
研究组 & 干预措施
test group (Group A)
Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel.
干预措施: Gengigel (Drug)
test group (Group A)
Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel.
干预措施: LASER (Device)
test group (Group B)
Surgical sites will be irradiated with diode laser only
干预措施: LASER (Device)
结局指标
主要结局
Landry's healing index
时间窗: Wound healing assessed by implementing Landry, Turnbull and Howley Healing index on the 3rd, 7th, 14th, 21st day, 1 month, 2 months and 3 months after the post-surgical procedure.
to asses the wound healing progress post-surgically in the 3 groups and see how photobiomodulation therapy and the application of hyaluronic acid can enhance the post-operative period. Five variables are assessed: tissue color, bleeding on palpation, the presence of granulation tissue, the incision margin and suppuration. It ranges from 1 to 5, with 1 indicating poor healing and 5 indicating excellent healing
Visual analogue scale
时间窗: Pain perception will be evaluated by using the visual analog scale on the 3rd, 7th, 14th, 21st day and 1 month of periodic follow-up
to asses the subjected level of pain by the patient throughout the healing process with a minimum score of 0 meaning no pain (best) and a maximum score of 10 meaning severe pain (worse)
次要结局
- Oral health impact profile 14 questions(pre-operative post-operative - on the 7th day - on the 14th day)
研究者
Hanan Rabih Danaf Naim
Principal Investigator
Beirut Arab University