CTRI Number |
CTRI/2019/09/021059 [Registered on: 04/09/2019] Trial Registered Prospectively |
Last Modified On: |
03/09/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
Buccally Displaced Flap |
Scientific Title of Study
|
Buccally Displaced Flap-A Novel Surgical Approach to Increase Keratinized Tissue in Implant Uncovering |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Ninad Milind Padhye |
Address |
Department of Periodontics, room no. 8, Lokhandwala Complex, Swami Samarth Nagar, Andheri West
Mumbai MAHARASHTRA 400053 India |
Phone |
|
Fax |
|
Email |
ninadpadhye91@gmail.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Ninad Milind Padhye |
Address |
Department of Periodontics, room no. 8, Lokhandwala Complex, Swami Samarth Nagar, Andheri West
Mumbai MAHARASHTRA 400053 India |
Phone |
|
Fax |
|
Email |
ninadpadhye91@gmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Ninad Milind Padhye |
Address |
Department of Periodontics, room no. 8, Lokhandwala Complex, Swami Samarth Nagar, Andheri West
Mumbai MAHARASHTRA 400053 India |
Phone |
|
Fax |
|
Email |
ninadpadhye91@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
Self funded.
Ninad Padhye. Department of Periodontics, room no. 8, Lokhandwala complex, Swami Samarth Nagar, Andheri West, Mumbai 400053 |
|
Primary Sponsor
|
Name |
Ninad Milind Padhye self funded |
Address |
B-1-7, Kripa Nagar, Irla, Vile Parle West, Mumbai 400056 |
Type of Sponsor |
Other [Self funded] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Ninad Milind Padhye |
Ceramco Dental Care |
Department of Periodontics, room no. 8, Lokhandwala Complex, Swami Samarth Nagar, Andheri West Mumbai |
9167147199
ninadpadhye91@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Intersystem Biomedica Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Deficient peri-implant buccal attached gingiva |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Buccally displaced flap |
A partial thickness gingival flap would be reflected over the dental implant and re-positioned buccally and sutured. |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Subjects with deficient buccal attached gingiva recruited 12 weeks after implant placement.
2. Systemically healthy.
3.single or multiple adjacent missing teeth in the maxilla or mandible. |
|
ExclusionCriteria |
Details |
1. Requiring bone augmentation procedures.
2. History of periodontal disease.
3. Diabetes mellitus |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Width of attached gingiva
Thickness of attached gingiva |
4 weeks and 1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/09/2019 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Brief Summary
|
Subjects with one or more missing teeth would be recruited. Dental implant procedure would be performed for them. During the second stage, a buccally displaced flap to augment the peri-implant keratinized mucosa would be performed. Following the healing phase, the implants would be restored with prosthesis. The width and thickness of the augmented keratinized mucosa would be assessed at 4 weeks and 1 year after the procedure. |