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CTRI Number  CTRI/2022/12/048131 [Registered on: 14/12/2022] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   GUM THICKNESS MODIFICATION TRIAL 
Scientific Title of Study   Regenerative phenotypic modification therapy: A non-randomized prospective pilot clinical trial (PMT TRIAL)  
Trial Acronym  REGPHEN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SARAVANAN SP 
Designation  CLASSIFIED SPECIALIST PERIODONTICS 
Affiliation  ARMY DENTAL CORPS 
Address  ARMY DENTAL CENTRE RESEARCH AND REFERRAL, DHAULAKUAN, DELHI CANTT, DELHI

South
DELHI
110010
India 
Phone  9637110906  
Fax    
Email  drsaravanan.sp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SARAVANAN SP 
Designation  CLASSIFIED SPECIALIST PERIODONTICS 
Affiliation  ARMY DENTAL CORPS 
Address  ARMY DENTAL CENTRE RESEARCH AND REFERRAL, DHAULAKUAN, DELHI CANTT, DELHI


DELHI
110010
India 
Phone  9637110906  
Fax    
Email  drsaravanan.sp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SARAVANAN SP 
Designation  CLASSIFIED SPECIALIST PERIODONTICS 
Affiliation  ARMY DENTAL CORPS 
Address  ARMY DENTAL CENTRE RESEARCH AND REFERRAL, DHAULAKUAN, DELHI CANTT, DELHI


DELHI
110010
India 
Phone  9637110906  
Fax    
Email  drsaravanan.sp@gmail.com  
 
Source of Monetary or Material Support  
Army Dental Centre Research and Referral Delhi 
 
Primary Sponsor  
Name  MINISTRY OF DEFENCE 
Address  DIRECTOR GENERAL DENTAL SERVICES AFRICA AVENUE NEW DELHI 
Type of Sponsor  Government funding agency 
 
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 
LT COL SARAVANAN SP  ARMY DENTAL CENTRE RESEARCH AND REFERRAL  DEPT OF PERIODONTOLOGY ARMY DENTAL CENTRE RESEARCH AND REFERRAL NEW DELHI
South
DELHI 
9637110906

drsaravanan.sp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ARMY DENTAL CENTRE DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (2) ICD-10 Condition: R69||Illness, unspecified, (3) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FLEXIBLE BONE GRAFT WITH ENAMEL MATRIX DERIVATIVES  The surgical phase will include lateral access tunnel technique under local anesthesia using bilateral access one tooth adjacent to sites of thin periodontal phenotype. A flexible bone substitute made of Beta Tricalcium phosphate with 2 mm thickness will be soaked in normal saline for 30 secs and 0.3mL of EMD (Enamel Matrix Derivative) will be coated on both surfaces of the flexible osseous substitute. The EMD treated osseous scaffold will be carefully introduced into the tunnel and molded over the labial bone surface, 2mm below the gingival margin. The access tunnel will be secured Monofilament Polyglycolic sutures. The intervention will be done only once at the time of surgical procedure and patients will be followed up at 12 months and 24 months 
Comparator Agent  NOT APPLICABLE BEING SINGLE ARM  NOT APPLICABLE BEING SINGLE ARM 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  (aa) Patients exhibiting thin periodontal osseous / soft tissue phenotype in 2 adjacent teeth on CBCT (Cone Beam Computed Tomography) / probe visibility method respectively.
(ab) Full mouth bleeding scores less than 20%.
(ac) Full mouth plaque scores less than 20%.
(ad) ASA-I physical status (American Society of Anesthesiologists).
 
 
ExclusionCriteria 
Details  (aa) Patients who underwent any form of soft tissue / hard tissue grafting procedure at the site of interest.
(ab) Current Smokers / Past Smokers within 1 year.
(ac) Current Pregnant / Planned Pregnancy / Lactating women.
(ad) Patient age group less than 18 or above 60 years.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Periodontal Phenotype  Baseline, 3 months, 6 months, 9 months 12 months, 15 months, 18 months and 24 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of gingival recession
Thickness of gingiva
Thickness of labial alveolar bone
Width of keratinised gingiva 
Baseline, 12 months, 24 months  
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/12/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NONE YET  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

(ii)     After CTRI approval, selected subjects will be explained about the details of the surgical procedure and a written informed consent will be obtained. All the subjects will undergo Phase I periodontal therapy as per laid out protocols and shall be reviewed after 4 to 6 weeks. They will be subjected to CBCT with low FOV (Field of Volume) restricted to the site of interest at baseline. The parameters observed will include the fwg. 

(aa)        Crestal gingival thickness (CGT) 

This radiological parameter will be measured as a distance between the facial surface of the gingiva and the labial bone surface at a distance of 2 mm from the edge of the alveolar crest, perpendicular to the osseous surface in CBCT. The measurement will be made at three points; mesial, midfacial & distal sites.  

(ab)     Thickness of labial plate of the alveolar crest (TLPAC)

This radiological parameter TLPAC will be measured in a plane perpendicular to the tooth axis, mid-buccal from the inner to the labial surface of the bone of the alveolar crest. The TLPAC was measured at 3 points: 2 mm, 4 mm, and 8 mm from the margin of the labial plate of the alveolar crest in the apical direction in CBCT. Each level measurements will be made at three points; mesial, midfacial & distal sites. 

(ac)     Width of keratinized tissue (WKT) 

It will be measured clinically using a periodontal probe calibrated      every 1 mm (UNC 15, Hu Friedy, USA). 

(ad)     Recession height (RH)

The presence or absence of MTR will be noted as a binary variable. When present, it will be measured clinically from cemento-enamel junction as landmark using a periodontal probe calibrated every 1 mm (UNC 15, Hu Friedy, USA). 

(iii)    All the four study parameters will be measured at baseline and 12 months and 24 months post-operatively by single operator / observer (PW) after calibrating for intra-operator reliability. The CBCT technique will be calibrated and standardized by the operator for intra-operator reliability. All the subjects will be included in standard supportive periodontal treatment regimen at interval of 3 months post-operatively. 

(iv)   The surgical phase will include lateral access tunnel technique under local anesthesia using bilateral access one tooth adjacent to sites of thin periodontal phenotype. A flexible bone substitute made of Beta Tricalcium phosphate with 2 mm thickness will be soaked in normal saline for 30 secs and 0.3mL of EMD (Enamel Matrix Derivative) will be coated on both surfaces of the flexible osseous substitute. The EMD treated osseous scaffold will be carefully introduced into the tunnel and molded over the labial bone surface, 2mm below the gingival margin. The access tunnel will be secured 6/0 Monofilament Polyglycolic sutures. The patients will be subjected to standard post-operative care and supportive periodontal treatment for once in 3 months and followed up to 24 months. 

(v)           Statistical Analysis

The data collected by the principal worker at ADC (R&R) will be compiled and subjected to statistical analysis. The statistical analysis will be done by relevant statistical methods using appropriate software. 

 
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