Soft Tissue MassNCT03628170
Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft
A study testing platelet rich fibrin and Free gingival graft in people with Soft Tissue Mass, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Mass
- What is being tested?
- platelet rich fibrin and Free gingival graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2018to Feb 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 25-50 years.
- Non- restorable teeth indicated for extraction.
- Good oral hygiene.
- Intact facial and lingual plates of bone, without infection or pathosis.
- Adequate apiacl bone for primaru stability
Who cannot join
- Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
- Presence of periodontal and/or periapical infection.
- Smokers.
- Non-compliant patients.
- Pregnancy or lactation in females.
- History of head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and dental medicine, Cairo University
Cairo, 11311 to 11668
Shaimaa Nasr, PhD, 01272789994, dr.shaimaanasr@gmail.com
Haya Hesham, Masters, 01001421350, shaimaanasr@live.com
About this study
Official title: Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study
Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.
Read the detailed description
Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.
- Conditions
- Soft Tissue Mass
- Being tested
- platelet rich fibrin, Free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich fibrinOther
platelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane.
Free gingival graftOther
Free gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation.
| Study group | Role | What they receive |
|---|---|---|
| PRF (Platelet -rich fibrin) group | Experimental | Extraction of the tooth followed by Platelet rich fibrin placed in the socket covered bu platelet rich fibrin membrane for socket preservation. Receives: Other: platelet rich fibrin |
| Free gingival graft group | Active comparator | Extraction of the tooth followed by using free gingival graft to cover the socket for socket preservation. Receives: Other: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue profile change
Optical scanning by optical scanner at baseline to the preoperative cast of the related area, then optical scanning to postoperative cast of the surgical area after 6 months. Then, superimposition between the two scans of the casts will be performed to measure the difference or change in the amount of soft tissue profile measured in millimeters between baseline and at 6 months
Measured: 6 months
Secondary outcomes (1)
Crestal bone level change
measured by Cone beam computed tomography (CBCT) taking the neighboring teeth as reference points, with superimposition between readings at baseline and at 6 months.
Superimposition will identify the difference or change in crestal bone level measured in millimeters between baseline and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start7 Jun 2018
- Primary completionJan 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue MassStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Hesham, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628170
- Sponsor's protocol ID
- version 3
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After reaching for the primary and secondary outcomes, international publication will be performed
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03628170
- Acronym / sponsor ID
- version 3
- Conditions
- Soft Tissue Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 14 Aug 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.
Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.
Detailed description
Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF (Platelet -rich fibrin) group | Experimental | Other: platelet rich fibrinExtraction of the tooth followed by Platelet rich fibrin placed in the socket covered bu platelet rich fibrin membrane for socket preservation. |
| Free gingival graft group | Active comparator | Other: Free gingival graftExtraction of the tooth followed by using free gingival graft to cover the socket for socket preservation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range 25-50 years.
- Non- restorable teeth indicated for extraction.
- Good oral hygiene.
- Intact facial and lingual plates of bone, without infection or pathosis.
- Adequate apiacl bone for primaru stability
Key exclusion criteria (6 listed)
- Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
- Presence of periodontal and/or periapical infection.
- Smokers.
- Non-compliant patients.
- Pregnancy or lactation in females.
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 |
|---|---|---|
| platelet rich fibrinplatelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane. | Other | PRF (Platelet -rich fibrin) group |
| Free gingival graftFree gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation. | Other | Free gingival graft group |
Primary outcome
Soft tissue profile change
Time frame: 6 months
Optical scanning by optical scanner at baseline to the preoperative cast of the related area, then optical scanning to postoperative cast of the surgical area after 6 months. Then, superimposition between the two scans of the casts will be performed to measure the difference or change in the amount of soft tissue profile measured in millimeters between baseline and at 6 months
1 secondary outcome
Crestal bone level change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided. After reaching for the primary and secondary outcomes, international publication will be performed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich fibrin and Free gingival graft in people with Soft Tissue Mass, run by Cairo University 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 5 inclusion and 6 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 14 Aug 2018. 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 Haya Hesham, Masters (01272789994, shaimaanasr@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue profile change (time frame: 6 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 14 Aug 2018.