| CTRI Number |
CTRI/2024/03/064180 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparingdifferent methods in the treatment of gum recession |
|
Scientific Title of Study
|
Clinical Evaluation of the Efficacy of Antibiotic along with Platelet Rich Fibrin Membrane and Sticky Bone in the Treatment of Gingival Recession - A Randomised Control 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 |
Rashika M |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU, Varanasi |
| Address |
Room no 5, 3rd floor, Department of Periodontology, Faculty of Dental Sciences, Trauma centre, BHU
Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7299604333 |
| Fax |
|
| Email |
rashika.muralisekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anju Gautam |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU, Varanasi |
| Address |
Room no 5, 3rd floor, Unit of Periodontology, Faculty of Dental Sciences, Trauma centre, BHU
Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8299867542 |
| Fax |
|
| Email |
dranjugautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashika M |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty of Dental Sciences, IMS, BHU, Varanasi |
| Address |
Room no 5, 3rd floor, Department of Periodontology, Faculty of Dental Sciences, Trauma centre, BHU
Varanasi
Uttar Pradesh
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7299604333 |
| Fax |
|
| Email |
rashika.muralisekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Rashika M |
| Address |
Room no 5, third floor, Department of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Rashika M |
Faculty of Dental Sciences , IMS, BHU |
Room no 5, 3rd floor, Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH |
7299604333
rashika.muralisekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,IMS, BHU, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingival Recession in the Permanent dentition (Miller’s Class I and II) causing esthetic concerns, root sensitivity and root caries. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gingival recession treatment using PRF membrane alone |
Under local anesthetic, mucoperiosteal flap will be reflected, extending both mesially and distally to get optimum access. Root planning will be carried out and the receipient bed will be prepared. Patients blood will be collected and centrifuged to obtain PRF, which will be molded to obtain a PRF membrane, which will be placed over the defect. The mucoperiosteal flap will be repositioned and secured with 4-0 resorbable suture, followed by a periodontal dressing. Dressing and sutures will be removed by 7-10 days of the surgery. The follow up for recession coverage will be done at 3months and at 6 months after surgery. |
| Intervention |
Gingival recession treatment using PRF membrane and sticky bone |
Under local anesthetic, mucoperiosteal flap will be reflected, extending both mesially and distally to get optimum access. Root planning will be carried out and the receipient bed will be prepared. Patients blood will be collected in 2 tubes and centrifuged to obtain PRF, bonegraft will be mixed to one tube of the PRF to obtain sticky bone and the other tube of PRF will be molded to obtain a PRF membrane. The sticky bone will be placed over the defect and covered by the PRF membrane. The mucoperiosteal flap will be repositioned and secured with 4-0 resorbable suture, followed by a periodontal dressing. Dressing and sutures will be removed by 7-10 days of the surgery. The follow up for recession coverage will be done at 3months and at 6 months after surgery. |
| Intervention |
Gingival recession treatment using PRF membrane, sticky bone and antibiotic solution |
Under local anesthetic, mucoperiosteal flap will be reflected, extending both mesially and distally to get optimum access. Root planning will be carried out and the receipient bed will be prepared. Patients blood will be collected in 2 tubes, both tubes will receive freshly prepared Amoxicillin solution to the blood prior to the centrifugation to obtain antibiotic incorported PRF, bonegraft will be mixed to one tube of the PRF to obtain sticky bone and the other tube of PRF will be molded to obtain a PRF membrane. The sticky bone will be placed over the defect and covered by the PRF membrane . The mucoperiosteal flap will be repositioned and secured with 4-0 resorbable suture, followed by a periodontal dressing. Dressing and sutures will be removed by 7-10 days of the surgery. The follow up for recession coverage will be done at 3months and at 6 months after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Gingival Recession (Miller’s Class I & II)
Presence of detectable CEJ.
Not using tobacco in any form.
Systemically healthy subjects with no contraindication to periodontal surgery.
Able to achieve good oral hygiene.
Subjects who gave written consent.
Subjects who were available for follow up.
|
|
| ExclusionCriteria |
| Details |
Presence of severe tooth malposition, rotation or clinically significant supraeruption.
Cervical or root caries, cervical abrasion, prosthetic crown and restorations involving cemento-enamel junction.
Pregnant and lactating mothers.
Hypersensitivity or allergy to the products used.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Recession/ Root coverage |
1.At baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Keratinized Gingival Width
2.Gingival Thickness
3.Relative Attachment Level
4.Probing Depth
5.Bone Regeneration |
1.At baseline, 3 months and 6months 2.At baseline, 3 months and 6months
3.At baseline, 3 months and 6months
4.At baseline, 3 months and 6months
5.At baseline and 6months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In gingival recession, bone dehiscence occurs along with soft tissue loss that makes it challenging to restore, as soft tissue passively follows the position and form of the underlying hard tissue. This study aims to explore clinical and radiographic effectiveness of PRF alone Vs PRF with sticky bone Vs Amoxicillin incorporated PRF and sticky bone in the management of Miller’s Class I and II Recession defects. |