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CTRI Number  CTRI/2025/06/089118 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative analysis of two techniques- Emdogain vs low level laser therapy for correction of gingival recession 
Scientific Title of Study   COMPARATIVE EVALUATION OF RECESSION COVERAGE FOLLOWING THE USE OF ADJUNCTIVE PHOTOBIOMODULATION OR BIOFUNCTIONALIZATION WITH EMDOGAIN FOR THE MANAGEMENT OF ISOLATED GINGIVAL RECESSION- A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deebika D 
Designation  MDS-POSTGRADUATE 
Affiliation  DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL 
Address  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  8682068462  
Fax    
Email  drdeebika27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Muthukumar 
Designation  Professor 
Affiliation  DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL 
Address  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9884118681  
Fax    
Email  muthukumars@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr S Muthukumar 
Designation  Professor 
Affiliation  DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL 
Address  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9884118681  
Fax    
Email  muthukumars@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
SRI RAMACHANDRA DENTAL COLLEGE AND HOSPITAL, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
 
Primary Sponsor  
Name  SELF FUNDED 
Address  DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DEEBIKA D  SRI RAMACHANDRA DENTAL HOSPITAL  Room number 5, DEPARTMENT OF PERIODONTOLOGY, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, 1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU 
8682068462

drdeebika27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  EMDOGAIN  CORONALLY ADVANCED FLAP + ADJUNCTIVE BIOFUNCTIONALIZATION USING EMDOGAIN 
Intervention  LOW LEVEL LASER  CORONALLY ADVANCED FLAP+ ADJUNCTIVE PHOTOBIOMODULATION USING LOW LEVEL DIODE LASER 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Systemically healthy patients
Presence of isolated (single tooth) Cairo’s RT1 (RT1-gingival recession with no loss of interproximal atatchment)
Patients with no medication known to interfere with periodontal tissue health/healing (steroids, calcium channel blockers, antiepileptic agents, immune-suppressants)
Non-smoker (= never smoker), or former smoker (= does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months)
 
 
ExclusionCriteria 
Details  Patients with abusive habits such as smoking and tobacco chewing
Patients with systemic diseases such as Diabetes mellitus, Hypertension.
Immunocompromised patients
Lingual recession in the selected teeth
Presence of malocclusion/patients with orthodontic therapy in progress and
Previous history of surgical periodontal therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
mean and complete root coverage percentages   1,3,6months 
 
Secondary Outcome  
Outcome  TimePoints 
wound healing, root coverage esthetic score and patient reported outcome measures  1,3,6months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial    
Date of First Enrollment (India)   25/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Gingival recession (GR) is a common mucogingival deformity with a global prevalence of 78.16%, most frequently affecting mandibular anteriors. It is defined as the apical shift of the gingival margin beyond the cementoenamel junction, leading to root surface exposure, dentin hypersensitivity, esthetic concerns, and root caries. Risk factors include a thin biotype, lack of attached gingiva, bone deficiencies, tooth malposition, and high frenum attachment. With rising esthetic demands, managing GR is essential for both periodontal health and optimal functional outcomes. Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) is considered the gold standard, achieving predictable root coverage (61.24–99%), while adjunctive therapies aim to further enhance clinical outcomes by improving wound healing and tissue regeneration. Photobiomodulation (PBM) therapy, utilizing low-level diode lasers (660–980 nm, 0.05–0.5 W), stimulates mitochondrial ATP production, accelerating wound healing, promoting neovascularization, reducing dentinal hypersensitivity, and modulating inflammation. Studies suggest PBM enhances root coverage and patient comfort. Enamel Matrix Derivatives (EMD), such as Emdogain, mimic the natural tooth development process, promoting angiogenesis, fibroblast proliferation, osteoblast differentiation, and anti-inflammatory effects. Systematic reviews indicate that EMD significantly improves complete root coverage when used as an adjunct to CAF. Additionally, studies suggest that combining EMD with CTG enhances clinical outcomes, including recession depth reduction and attachment gain. Despite the well-documented individual benefits of PBM and EMD, comparative evaluations of these adjuncts with CAF+CTG are limited. This randomized controlled clinical trial aims to systematically compare the efficacy of CAF+CTG with adjunctive PBM and CAF+CTG with adjunctive EMD in improving clinical parameters and patient-reported outcomes, bridging this knowledge gap and optimizing treatment approaches for gingival recession management.

 
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