Pain, PostoperativeNCT03814707
Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival Graft
A study testing Topical application of 0.2% hyaluronic acid gel and Platelet rich fibrin in people with Pain, Postoperative, run by mostafa soliman at 1 site in Egypt.
Trial summary
Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure . . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Topical application of 0.2% hyaluronic acid gel and Platelet rich fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2019to Jul 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mucogingival defects scheduled for free gingival graft
- Age at least 18 years.
- Not having any systemic disease that could compromise wound healing
- No previous periodontal surgery on the experimental sites.
Who cannot join
- Systemic diseases that may be a contraindication for any surgeries.
- Loss of maxillary premolars and molars.
- Pregnancy or lactation
- Smoking
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine - Cairo University -
Giza, 12613
Mostafa M Soliman, B.D.S, 002-01007034062, drshoo_2010@hotmail.com
Mona M Shoeib, P.H.D, 002-01223102216, monashoeib@gmail.com
About this study
Official title: Clinical Comparison of Platelet Rich Fibrin Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Wound Healing After Free Gingival Graft Harvesting: A Randomized Clinical Trial
Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure .
.
Read the detailed description
- Patients of both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history.
- Clinical Examination.
After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. The free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 .
The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures.
Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was introduced by Choukroun \& coworkers. PRF requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. After collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. After the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack
control group Control group: As the intervention group but the palatal wound will receive a .2% hyaluronic acid gel then covered by periodontal dressing
..
- Conditions
- Pain, Postoperative
- Being tested
- Topical application of 0.2% hyaluronic acid gel, Platelet rich fibrin
- Keywords
- gingival recession, gingival augmentation, free gingival graft, platelet rich fibrin in wound healing, 2 steps free gingival graft, hyaluronic acid in wound healing
- Medical subject headings
- Pain, Postoperative, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of 0.2% hyaluronic acid gelDrug
Also called gengigel
Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting
Platelet rich fibrinBiological
Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.
| Study group | Role | What they receive |
|---|---|---|
| Topical application 0.2%Hyaluronic Acid | Active comparator | Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack Receives: Drug: Topical application of 0.2% hyaluronic acid gel |
| Platelet Rich Fibrin | Experimental | Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack. Receives: Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst
Measured: 1 week
Secondary outcomes (1)
wound healing
Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start10 Jan 2019
- Primary completion1 Jun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Model description
- Parallel Assignment * A randomized clinical trial. * Parallel group study. * A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mostafa soliman
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, mostafa soliman, Cairo University
- Investigators
- Mona M Shoeib, P.H.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814707
- Sponsor's protocol ID
- CEBD-CU-2018-09-17
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Platelet Rich Fibrin Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Wound Healing After Free Gingival Graft Harvesting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03814707
- Acronym / sponsor ID
- CEBD-CU-2018-09-17
- Conditions
- Pain, Postoperative
- Keywords
- gingival recession, gingival augmentation, free gingival graft, platelet rich fibrin in wound healing, 2 steps free gingival graft, hyaluronic acid in wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- mostafa solimanUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 24 Jan 2019 (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.
Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure .
.
Detailed description
- Patients of both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history.
- Clinical Examination.
After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. The free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 .
The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures.
Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was introduced by Choukroun \& coworkers. PRF requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. After collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. After the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack
control group Control group: As the intervention group but the palatal wound will receive a .2% hyaluronic acid gel then covered by periodontal dressing
..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment * A randomized clinical trial. * Parallel group study. * A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
| Arm | Type | Receives |
|---|---|---|
| Topical application 0.2%Hyaluronic Acid | Active comparator | Drug: Topical application of 0.2% hyaluronic acid gelTopical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack |
| Platelet Rich Fibrin | Experimental | Biological: Platelet rich fibrinPalatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mucogingival defects scheduled for free gingival graft
- Age at least 18 years.
- Not having any systemic disease that could compromise wound healing
- No previous periodontal surgery on the experimental sites.
Key exclusion criteria (4 listed)
- Systemic diseases that may be a contraindication for any surgeries.
- Loss of maxillary premolars and molars.
- Pregnancy or lactation
- Smoking
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 |
|---|---|---|
| Topical application of 0.2% hyaluronic acid gelAlso: gengigelTopical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting | Drug | Topical application 0.2%Hyaluronic Acid |
| Platelet rich fibrinPlacement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack. | Biological | Platelet Rich Fibrin |
Primary outcome
post operative pain
Time frame: 1 week
Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst
1 secondary outcome
wound healing
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Mona M Shoeib, P.H.D study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical application of 0.2% hyaluronic acid gel and Platelet rich fibrin in people with Pain, Postoperative, run by mostafa soliman at 1 site in Egypt.
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 4 inclusion and 4 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 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mostafa M Soliman, B.D.S (002-01007034062, drshoo_2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: 1 week). 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 28 Jan 2019.