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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035820
Receipt No. R000040748
Scientific Title comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in treatment of isolated gingival recessions- a randomized clinical trial
Date of disclosure of the study information 2019/02/08
Last modified on 2019/02/08

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Basic information
Public title comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in treatment of isolated gingival recessions- a randomized clinical trial
Acronym comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in the treatment of isolated gingival recessions
Scientific Title comparative evaluation of coronally positioned tunnel and coronally advanced flap with platelet rich fibrin in treatment of isolated gingival recessions- a randomized clinical trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yusra Akhtar
Organization ITS Dental College,Hospital and Research Centre ,Greater Noida,Uttar Pradesh,India
Division name Periodontics
Zip code
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
1st name
Middle name
Last name Yusra Akhtar
Organization ITS Dental College,Hospital and Research Centre ,Greater Noida,Uttar Pradesh,India
Division name Periodontics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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