| 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
|
|
|
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
|
|
|
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. |