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Clinical Trials/NCT06433973
NCT06433973
Not yet recruiting
Not Applicable

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

Postgraduate Institute of Dental Sciences Rohtak1 site in 1 country51 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Enrollment
51
Locations
1
Primary Endpoint
Keratinised tissue width
Status
Not yet recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Keratinised tissue width

Time Frame: 6 months

recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.

interproximal Clinical attachment level (iCAL)

Time Frame: 6 months

recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region

Percentage root coverage

Time Frame: 6 months

( Preoperative recession depth) - (Postoperative recession depth) × 100 Preoperative recession depth

Secondary Outcomes

  • Pocket probing depth(6 months)
  • Recession depth(6 months)
  • Bleeding on probing (BOP)(6 months)
  • change in Gingival thickness(6 months)
  • Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)(6 months)
  • Buccal Clinical attachment level(6 months)
  • Recession width(6 months)

Study Sites (1)

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