UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035820 |
|---|---|
| Receipt number | 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 18:51:49 |
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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
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
akhtaryusra@gmail.com
Sponsor or person
Institute
Self founding
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040748
