Clinical trial NCT06433973: Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects
Official title: Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root.

Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs).

Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement.

It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.

Detailed description: Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results.

Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization.

.LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group

Eligibility criteria: Inclusion Criteria:

* Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
* Systemically healthy individuals.
* Absence of clinical tooth mobility.
* Age \>18 years old.
* A full mouth plaque index \< 20%
* Patient showing adequate compliance and willing to participate in the study.

Exclusion Criteria:

* Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
* patient with active periodontal disease
* smokers and tobacco users
* mal-alingned lower anteriors.
* patients who had already undergone root coverage procedure on the selected site.
* pregnant and lactating females
* Involved tooth with trauma from occlusion.
* Involved tooth with prosthesis.
* Endodontically involved/ RCT treated tooth
* Tooth with cervical abrasion / undetectable CEJ/ carious.

Primary outcomes:
measure: Percentage root coverage
timeFrame: 6 months
measure: Keratinised tissue width
timeFrame: 6 months
measure: interproximal Clinical attachment level (iCAL)
timeFrame: 6 months
Secondary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 6 months
measure: Buccal Clinical attachment level
timeFrame: 6 months
measure: change in Gingival thickness
timeFrame: 6 months
measure: Recession depth
timeFrame: 6 months
measure: Recession width
timeFrame: 6 months
measure: Pocket probing depth
timeFrame: 6 months
measure: Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: PGIDS, Rohtak
name: Anisha Kumari, BDS
role: PRINCIPAL_INVESTIGATOR
References: