Gingival RecessionNCT03328442
Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.
A study testing VISTA Technique and modified coronally advanced flap in people with Gingival Recession, run by Cairo University.
Trial summary
VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- VISTA Technique and modified coronally advanced flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (18-55) Miller's classI and II multiple GR width of KG>2 mm
Who cannot join
- Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Patient Satisfaction After Root Coverage Procedure Using VISTA Technique Compared to Modified Coronally Advanced Flap Technique in Conjunction With Platelet Rich Fibrin-membrane.
VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession
Read the detailed description
Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects.
Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively.
Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.
- Conditions
- Gingival Recession
- Being tested
- VISTA Technique, modified coronally advanced flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTA TechniqueProcedure or surgery
Also called Vestibular incision subperiosteal tunnel access
VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane
modified coronally advanced flapProcedure or surgery
Also called MCAF
modified coronally advanced flap with PRF membrane for Treatment of recession class I and II
| Study group | Role | What they receive |
|---|---|---|
| Vista technique | Experimental | The vista technique with PRF membrane uses a Vestibular incision subperiosteal tunnel access in combination with Platelet rich fibrin membrane to treat gingival recession defects. Receives: Procedure: VISTA Technique |
| modified coronally advanced flap | Active comparator | A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects. Receives: Procedure: modified coronally advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Using a questionnaire which are designed in a dichotomous fashion (yes or no ) and calculated by percentage of answering yes.
it not a scale, the following questions will be asked to the patients;
- did you feel pain in spite of the medication prescribed?
- did you perceive the course of healing unexpected restriction?
- did you experience any remaining symptoms of parasethesia?
- would you described the under taken effort as reasonable?
- have your expectations been fulfilled?
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study startMar 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah salaheldin, Cairo University
- Investigators
- Azza Ezzelarab, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328442
- Sponsor's protocol ID
- CEBD-CU-2017-10-30
- Status last verified
- Jan 2018
- First submitted
- 29 Oct 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
PubMed 22140667Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
PubMed 11022782Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
PubMed 24117676
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction After Root Coverage Procedure Using VISTA Technique Compared to Modified Coronally Advanced Flap Technique in Conjunction With Platelet Rich Fibrin-membrane.
- ClinicalTrials.gov ID
- NCT03328442
- Acronym / sponsor ID
- CEBD-CU-2017-10-30
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession
Detailed description
Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects.
Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively.
Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vista technique | Experimental | Procedure: VISTA TechniqueThe vista technique with PRF membrane uses a Vestibular incision subperiosteal tunnel access in combination with Platelet rich fibrin membrane to treat gingival recession defects. |
| modified coronally advanced flap | Active comparator | Procedure: modified coronally advanced flapA modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age (18-55) Miller's classI and II multiple GR width of KG>2 mm
Key exclusion criteria (1 listed)
- Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VISTA TechniqueAlso: Vestibular incision subperiosteal tunnel accessVISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane | Procedure or surgery | Vista technique |
| modified coronally advanced flapAlso: MCAFmodified coronally advanced flap with PRF membrane for Treatment of recession class I and II | Procedure or surgery | modified coronally advanced flap |
Primary outcome
Patient satisfaction
Time frame: after 6 months
Using a questionnaire which are designed in a dichotomous fashion (yes or no ) and calculated by percentage of answering yes. it not a scale, the following questions will be asked to the patients; 1. did you feel pain in spite of the medication prescribed? 2. did you perceive the course of healing unexpected restriction? 3. did you experience any remaining symptoms of parasethesia? 4. would you described the under taken effort as reasonable? 5. have your expectations been fulfilled?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 22140667Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
- Background: PubMed 11022782Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
- Background: PubMed 24117676Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
- Individual participant dataSharing planned: Undecided
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Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azza Ezzelarab, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing VISTA Technique and modified coronally advanced flap in people with Gingival Recession, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Saleh, Master (01001628350, mssaleh213@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328442, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.