Gingival RecessionNCT03695549
Evaluation of Root Coverage After the Use of Coronally Advanced Flap Either With Advanced Paltelet Rich Fibrin or Subepithilial Connective Tissue Graft in Treatment of Miller Class I and II Gingival Recession.
A study testing CAF + (A-PRF) and CAF+SCTG in people with Gingival Recession, run by Cairo University.
Trial summary
patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- CAF + (A-PRF) and CAF+SCTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy patients 18 years old and older both males and females.
- Good oral hygiene after phase I therapy.
- Miller's class I or II gingival recession.
- Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
- Cooperative patients able and accept to come for follow up appointments
Who cannot join
- Pregnant or lactating females.
- Current Smokers.
- Patients with any systemic disease that may affect the periodontal healing.
- Teeth with endodontic treatment, buccal restoration or caries.
- Patients with poor oral hygiene
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial
patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.
Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.
Read the detailed description
- Population (P): Patients with single Miller class I, II gingival recessions.
- Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).
- Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).
- Primary Outcome (O): Root coverage (mm).
- Time frame: 9 months.
- Study design: Randomized controlled clinical trial.
- Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University
- Conditions
- Gingival Recession
- Being tested
- CAF + (A-PRF), CAF+SCTG
- Keywords
- advanced platelet rich fibrin,A-PRF
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF + (A-PRF)Procedure or surgery
advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .
CAF+SCTGProcedure or surgery
cornally advanced flap plus subepithilial connective tissue graft harvested from the palate
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | CAF+ APRF Receives: Procedure: CAF + (A-PRF) |
| control | Active comparator | CAF+SCTG Receives: Procedure: CAF+SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
root coverage
measured in millimeter
Measured: 9 months
Secondary outcomes (9)
Gingival esthetics
Root coverage esthetic score
Measured: 9 months
Recession width
measured in millimeter
Measured: 9 months
Clinical attachment level
measured in millimeter
Measured: 9 months
Width of keratinized gingiva
measured in millimeter
Measured: 9 months
Probing depth
measured in millimeter
Measured: 9 months
Gingival thickness
measured in millimeter
Measured: 9 months
Post-operative pain
Visual analog scale (VAS) Questionnaire
Measured: measured daily for the first 2 weeks post- operatively.
Patient Satisfaction
Post-Surgical Patient Satisfaction Questionnaire
Measured: 9 months
Early wound healing
Early wound healing index
Measured: 1,2,4 weeks post- surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba samir, Cairo University
- Investigators
- Heba Samir Mhmoud, assistant lecturer, Principal investigator, Cairo UniversityManal M Hosny, professor, Study director, Cairo UniversityEngi A Mahmoud, assistant professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695549
- Sponsor's protocol ID
- assistant lecturer
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03695549
- Acronym / sponsor ID
- assistant lecturer
- Conditions
- Gingival Recession
- Keywords
- advanced platelet rich fibrin,A-PRF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 4 Oct 2018 (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.
patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.
Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.
Detailed description
- Population (P): Patients with single Miller class I, II gingival recessions.
- Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).
- Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).
- Primary Outcome (O): Root coverage (mm).
- Time frame: 9 months.
- Study design: Randomized controlled clinical trial.
- Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Procedure: CAF + (A-PRF)CAF+ APRF |
| control | Active comparator | Procedure: CAF+SCTGCAF+SCTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy patients 18 years old and older both males and females.
- Good oral hygiene after phase I therapy.
- Miller's class I or II gingival recession.
- Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
- Cooperative patients able and accept to come for follow up appointments
Key exclusion criteria (5 listed)
- Pregnant or lactating females.
- Current Smokers.
- Patients with any systemic disease that may affect the periodontal healing.
- Teeth with endodontic treatment, buccal restoration or caries.
- Patients with poor oral hygiene
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 |
|---|---|---|
| CAF + (A-PRF)advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap . | Procedure or surgery | intervention |
| CAF+SCTGcornally advanced flap plus subepithilial connective tissue graft harvested from the palate | Procedure or surgery | control |
Primary outcome
root coverage
Time frame: 9 months
measured in millimeter
9 secondary outcomes
Gingival esthetics
Time frame: 9 months
Recession width
Time frame: 9 months
Clinical attachment level
Time frame: 9 months
Width of keratinized gingiva
Time frame: 9 months
Probing depth
Time frame: 9 months
Gingival thickness
Time frame: 9 months
Post-operative pain
Time frame: measured daily for the first 2 weeks post- operatively.
Patient Satisfaction
Time frame: 9 months
Early wound healing
Time frame: 1,2,4 weeks post- surgical
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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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.
Heba Samir Mhmoud, assistant lecturer principal investigator
Cairo University
Manal M Hosny, professor study director
Cairo University
Engi A Mahmoud, assistant professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing CAF + (A-PRF) and CAF+SCTG 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 5 inclusion and 5 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 9 Oct 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 heba samir mahmoud, assistant lecturer (01222541606, heba227@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
root coverage (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.