| 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
|
|
|
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
|
|
|
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. |