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	Name  Address  NIL  NIL
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	Status  Not Applicable
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.