Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Test group 1 - CM+LLLT+VISTA; Procedure: Test group 2 - CM+VISTA; Procedure: Control group - SCTG+VISTA

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

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shikha Tewari, MDS; Phone Number: 8708249475; Email: drshikhatewari@yahoo.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group 1 - CM+LLLT+VISTA; After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser.	Procedure: Test group 1 - CM+LLLT+VISTA; After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec.
Experimental: Test group 2 - CM+VISTA; After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique.	Procedure: Test group 2 - CM+VISTA; After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures.
Other: Control group - SCTG+VISTA; Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.	Procedure: Control group - SCTG+VISTA; Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage root coverage	( Preoperative recession depth) - (Postoperative recession depth) × 100 Preoperative recession depth	6 months
Keratinised tissue width	recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.	6 months
interproximal Clinical attachment level (iCAL)	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing (BOP)	will be recorded as 1(present) if bleeding occurs within 15 seconds of probing and 0(absent) if no bleeding occurs. It will be calculated in percentage %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by hundred. It will be designed as percentage sites with bleeding on probing	6 months
Buccal Clinical attachment level	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 mid-buccal region	6 months
change in Gingival thickness	The GT will be assessed by probe transparency (TRAN) method . Gingival thickness will be measured from the keratinized mucosa to the periosteum with a finger spreader and a silicon slider and digital calliper at a point lying in the centre of a line drawn from the gingival margin to mucogingival junction	6 months
Recession depth	recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at the mid-labial region.	6 months
Recession width	recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction	6 months
Pocket probing depth	Measured in mm from the crest of the gingival margin to the base of the pocket at the mid-labial region	6 months
Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)	The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. Postoperative pain using visual analog scale at treated site (VAS: a scale from 0-10 ; 0 means no pain/discomfort, 10 means maximum pain /discomfort )	6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Anisha Kumari, BDS, PGIDS, ROHTAK

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Anisha Kumari Perio 24/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No