Soft Tissue AugmentationNCT03224442
Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle
A study testing PRF and Palatal Pedicle in people with Soft Tissue Augmentation, run by Cairo University.
Trial summary
Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation
- What is being tested?
- PRF and Palatal Pedicle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Oct 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of periodontal disease or a periapical infection
- Adequate native bone to achieve implant primary stability
- The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.
Who cannot join
- Systemic conditions/disease that contraindicated surgery
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- Patients who have inadequate interarch space for the prosthetic part.
About this study
Official title: Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Read the detailed description
Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score
- Conditions
- Soft Tissue Augmentation
- Being tested
- PRF, Palatal Pedicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFProcedure or surgery
soft tissue augmentation by prf
Palatal PedicleProcedure or surgery
soft tissue augmentation by palatal pedicle
| Study group | Role | What they receive |
|---|---|---|
| PRF with immediate implants | Experimental | Immediate implants placed and covered with two prf layers Receives: Procedure: PRF |
| palatal pedicle graft | Active comparator | immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft Receives: Procedure: Palatal Pedicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score
photographs
Measured: 5 months
Secondary outcomes (7)
facial gingival thickness
probe
Measured: 5 months
mid-buccal gingival level
probe
Measured: 5 months
interproximal gingival level
probe
Measured: 5 months
- width of keratinized gingiva (KG
probe
Measured: 5 months
Crestal bone loss
CBCT
Measured: 5 months
Implant stability
ostel
Measured: 5 months
Pain
VAS
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AugmentationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew George Edward Aziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224442
- Sponsor's protocol ID
- Philoprotocol
- Status last verified
- Nov 2017
- First submitted
- 12 Jul 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03224442
- Acronym / sponsor ID
- Philoprotocol
- Conditions
- Soft Tissue Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 21 Jul 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.
Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Detailed description
Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF with immediate implants | Experimental | Procedure: PRFImmediate implants placed and covered with two prf layers |
| palatal pedicle graft | Active comparator | Procedure: Palatal Pedicleimmediate implant placement followed by soft tissue augmentation by oalatal pedicle graft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Absence of periodontal disease or a periapical infection
- Adequate native bone to achieve implant primary stability
- The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.
Key exclusion criteria (5 listed)
- Systemic conditions/disease that contraindicated surgery
- Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- Patients who have inadequate interarch space for the prosthetic part.
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 |
|---|---|---|
| PRFsoft tissue augmentation by prf | Procedure or surgery | PRF with immediate implants |
| Palatal Pediclesoft tissue augmentation by palatal pedicle | Procedure or surgery | palatal pedicle graft |
Primary outcome
Pink Esthetic Score
Time frame: 5 months
photographs
7 secondary outcomes
facial gingival thickness
Time frame: 5 months
mid-buccal gingival level
Time frame: 5 months
interproximal gingival level
Time frame: 5 months
- width of keratinized gingiva (KG
Time frame: 5 months
Crestal bone loss
Time frame: 5 months
Implant stability
Time frame: 5 months
Pain
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PRF and Palatal Pedicle in people with Soft Tissue Augmentation, 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 3 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 7 Nov 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (time frame: 5 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 7 Nov 2017.