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临床试验/CTRI/2025/04/084774
CTRI/2025/04/084774尚未招募不适用

Clinical efficacy of tunnelled coronally advanced flap and amnion chorion membrane with the adjunct use of hyaluronic acid and low-level laser therapy for multiple gingival recession: randomized controlled trial

Madhumitha M1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Gingival biotype

研究概览

简要总结

Gingival recession (GR) or soft tissue recession is defined as the displacement of the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth or the platform of a dental implant. It is associated with poor aesthetics, dentinal hypersensitivity, and a negative impact on the oral health- related quality of life of an individual. 

Coronally advanced flap has several disadvantages, hence to overcome these challlenges,, Barootchi and et.al (2022) introduced a technique, tunnelled coronally advanced flap (TCAF) that combined the advantage of CAF and tunnelling technique (TUN) to gain access and improve graft stabilization while preserving the integrity of the papilla, for treatment.

Autograft tissue currently remains the “gold standard” of periodontal plastic surgery but significantly increases patient morbidity.

Amnion chorion membrane (ACM) exert anti-inflammatory, angiogenic, antifibrotic, antimicrobial effects low immunogenicity.

In recent years, low-level lasers have also been evaluated regarding their efficacy in wound healing‑ process in both medical and dental fields. Tissue repair phase in wound healing begins on the third day and lasts about two weeks, involves fibroblast proliferation and collagen genesis. The supplementation of LLLT at this point leads to expedited wound-healing events can be used as adjunct in promoting the healing and improve the outcome of periodontal flap procedures.

Hyaluronic acid (HA) is a major component of the extra cellular matrix in almost all tissues and suppresses tissue break down activating metalloproteinase inhibitors. HA is a promising adjunct for promoting faster wound healing when used in post periodontal flap surgery.

Combination of photobiomodulation therapy (PBMT) and HA gel application has proven to show significant clinical results by improving the healing outcome and decreases the time required for wound healing and re-epithelialization.

Patients with multiple maxillary gingival recession with cairos RT1/RT2 will be treated . 

Group A : patients will be treated with Tunnelled coronally advanced flap technique followed by placement of amnion chorion membrane.

Group B: patients will be treated with Tunnelled coronally advanced flap technique followed by placement of amnion chorion membrane followed by low level laser therapy prior to pack placement

Group C: : patients will be treated with Tunnelled coronally advanced flap technique and 0.2% hyaluronic acid gel will be applied in the root surface and amnion chorion membrane. post suturing patients are subjected to low level laser therapy followed by pack placement.

Thus, this study aims to evaluate the efficacy of TCAF and ACM with LLLT and HA.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Systemically healthy patients male or female of age group 18 – 60 years.
  • 2.Teeth selection: Upper arch with multiple recession with clinical evidence of Cairos RT1/RT2 gingival recession.
  • 3.Width of keratinized gingiva atleast 2mm 4.Treated cervical abrasion 5.Patients who agree to participate in the study by signing the informed consent and ability to perform adequate oral hygiene.
  • 5.Full mouth plaque and gingival index score of less than 20% 6.Absence of any malposition tooth.

排除标准

  • 1.Subjects who have received periodontal flap/regenerative therapy within the past 6 months.
  • 2.Patients who have received antibiotic therapy within the past 6 months 3.Pregnant and lactating patients 4.Smokers
  • Fixed orthodontic and removable appliances
  • Patients who demonstrate poor oral hygiene maintenance after Phase I therapy.
  • Systemic illness known to affect the outcomes of periodontal therapy, such as uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g., HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing.
  • 8.Patients with any known allergy to drugs 9.Patients with severe non carious cervical lesions (NCCL).

结局指标

主要结局

Gingival biotype

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Width of the keratinized gingiva

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Complete root coverage

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Mean root coverage

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Root coverage Esthetics

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Healing Index by Landry et al

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Percentage of gingival recession defect coverage

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Gingival recession depth

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

Gingival recession width

时间窗: baseline,3rd day, 7th day, 14th day, 21st day, 3rd month, 6th month

次要结局

  • Following will be the secondary outcomes to be measured:(1.Patient Reported Outcome Measures(PROM))

研究者

发起方
Madhumitha M
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Madhumitha M

Manipal College of Dental College

研究点 (1)

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