UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in treatment of isolated gingival recessions- a randomized clinical trial
Title of the study (Brief title)	comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in the treatment of isolated gingival recessions
Region	Asia(except Japan)

Condition
Condition	Gingival recession
Classification by specialty	Aesthetic surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of Coronally positioned tunnel and Coronally advanced flap using PRF in treatment of gingival recession. To compare pre and post operative gingival marginal levels to assess root coverage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	pocket probing depth(PPD), clinical attachment level (CAL),recession depth(RD),recession width(RW),width of keratinized gingiva (KTW)and gingival biotype(BT)recorded at baseline and re-evaluated after 6 months
Key secondary outcomes	Ancillary parameters included Gingival index (Loe and Silness,1963) and Plaque index (Silness and Loe,1964) which were recorded at baseline and re-evaluated after 1 month and 6 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Coronally Advanced Flap with Platelet Rich Fibrin
Interventions/Control_2	Coronally Positioned Tunnel with Platelet RichFibrin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with bilateral isolated Miller's Class I gingival recessions Male and females in age range of 18 -60 years
Key exclusion criteria	1.) Patients with any systemic diseases known to predispose to periodontal disease 2.) Pregnant and lactating mothers 3.) Patients with deleterious habits like smoking, alcohol consumption, tobacco chewing, betelnut chewing 4.) Patients with psychiatric illnesses 5.) Periodontal treatment within the previous 12 months 6.) Use of systemic antibiotics within the previous 6 months 7.) Use of hormonal contraceptives
Target sample size	10

Research contact person
Name of lead principal investigator	Yusra Akhtar
Organization	ITS Dental College,Hospital and Research Centre ,Greater Noida,Uttar Pradesh,India
Division name	Periodontics
Address	Plot no.47,Knowledge Park III,Greater Noida ,Uttar Pradesh,India
TEL	91-9760305474
Email	akhtaryusra@gmail.com

Public contact
Name of contact person	Yusra Akhtar
Organization	ITS Dental College,Hospital and Research Centre ,Greater Noida,Uttar Pradesh,India
Division name	Periodontics
Address	Plot no.47,Knowledge Park III,Greater Noida ,Uttar Pradesh,India
TEL	91-9760305474
Homepage URL
Email	akhtaryusra@gmail.com

Sponsor
Institute	Self founding
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Indian

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	ITS dental college,Hospital and Research centre,Plot no.47,Knowledge Park III,Greater Noida ,Uttar Pradesh,India

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 11 Day
Anticipated trial start date	2016 Year 11 Month 11 Day
Last follow-up date	2018 Year 07 Month 12 Day
Date of closure to data entry	2018 Year 07 Month 12 Day
Date trial data considered complete	2018 Year 07 Month 12 Day
Date analysis concluded	2018 Year 10 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Results of the study revealed improvement in all clinical parameters from baseline to 6 months with both techniques.Ancillary parameters also showed improvement from baseline values.
Other related information	Treatment 2(CPT with PRF) demonstrated significant improvement in PPD,Clincal attachment level,recession depth,recession width which proves it to be equally efficacious to CAF and it can be used as an alternative treatment modality for gingival recession.

Management information
Registered date	2019 Year 02 Month 08 Day
Last modified on	2019 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040748