Thickening; GingivalPhase 3NCT04864197
Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant
A Phase 3 study testing platelet rich fibrin in people with Thickening; Gingival, run by University of Baghdad at 1 site in Iraq.
Trial summary
we used prf with dental implant treatment to find out whether prf has an effect on increasing the soft tissue thickness and keratinized tissue width Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thickening; Gingival
- What is being tested?
- platelet rich fibrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIraq
- Study dates
- 19 Dec 2019to 15 Jul 2021
- Phase
- Phase 3
- 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 greater than 18 years old without systemic diseases and having good oral hygiene (with D1-D3 bone density).
Who cannot join
- general contraindications to implant surgery.
- patients with a history of severe periodontitis.
- bone augmentation required.
- smokers.
- treated or under treatment with intravenous aminobisphosphonates.
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
Zaid M Yasser, M.S.c contact
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry / University of Baghdad
Baghdad, 10047
About this study
we used prf with dental implant treatment to find out whether prf has an effect on increasing the soft tissue thickness and keratinized tissue width
Read the detailed description
Clinical oral implant related research is facing many interesting challenges. One of them is to create and maintain stable soft and hard tissues around osseointegrated oral implants.
It was suggested in a classic study that a minimum of 2 mm of keratinized mucosa (KM) around natural teeth is necessary to maintain gingival health. The lack of a sufficient wide zone of KM has been investigated as a potential contributing factor for peri- implant disease and therefore might influence the long- term success of oral implants.
Various studies have found a negative influence of the absence of KM on plaque accumulation. Oral implants with a narrow zone of KM (<2 mm) frequently exhibit significantly higher plaque scores than those with wider zones of KM. Even a subdivision can be made between KM and attached KM (AKM). A statistically significant higher plaque accumulation and gingival inflammation around implants in the groups with KM <2 mm and AKM <1 mm was observed. However, this could not be confirmed in another study.
Interestingly, the presence of an adequate band of KM adjacent to the implant seems to reduce inflammation, hyperplasia and recession of the marginal peri- implant soft tissues. Furthermore, it might facilitate restorative procedures, improve aesthetics and enable the patient to maintain an adequate oral hygiene without irritation or discomfort.
In particular, in the lower jaw, a scarce amount of KM can be regularly encountered. A reduced height of the alveolar process, due to crestal bone resorption, result in loss of KM due to the reduced distance between the bone crest and "genetically defined" position of the mucogingival line. Notably, in the posterior segments of the lower jaw, a narrow KM might be related to muscle pull, high frenulum attachments and a shallow vestibule.
Today, the golden standard to augment KM is a free gingival graft (FGG) harvested from the palate. The main problem with this technique is the morbidity for the patient as it involves a second surgical site. Reported problems following FGG procedure are pain, change in diet, paresthesia, herpetic lesion, mucocele, arteriovenous shunt and excessive bleeding.
To overcome this problem, different authors have proposed alternative techniques and materials to augment keratinized tissue around teeth and oral implants.
Various studies have substantiated the viability of platelet concentrates on enhancement of osseous and associated tissue healing and PRF is one of the recent innovations of various platelet concentrates.
Platelet- rich fibrin (PRF) is a 2nd generation platelet concentrate, which was introduced by Choukroun et al in 2001. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Its 3- dimensional fibrin network promotes neovascularization, accelerates wound closing and fast cicatricle tissue remodeling. Platelet concentrates are considered a source of autologous growth factors that promote cell migration and proliferation. Given that PRF is produced without using any additive, the fibrin polymerization occurs in a physiological way, resulting in a similar fibrin network as the one formed during natural healing.
Studies show a constant release of growth factors such as PDGF (platelet-derived growth factor) or TGF-b (transforming growth factor) for at least 1 week up to 28 days and proved its accelerating effect on the healing process.
- Conditions
- Thickening; Gingival
- Being tested
- platelet rich fibrin
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich fibrinBiological
Also called PRF
prf membrane placement over implant site for gingival thickening
| Study group | Role | What they receive |
|---|---|---|
| prf group | Experimental | prf membrane placement over implant site for gingival thickening Receives: Biological: platelet rich fibrin |
| control group | Experimental | no prf placement Receives: Biological: platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring gingival thickness
transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness
Measured: 6 months
Secondary outcomes (1)
keratinized tissue width
by using periodontal probe
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 posted28 Apr 2021
- Study start19 Dec 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thickening; GingivalStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussain Falah Mohsen, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864197
- Sponsor's protocol ID
- U0005B2O
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 2021
- Last updated
- 28 Apr 2021
- 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 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Keratinized Gingiva With and Without PRF Application in Patients With Dental Implant
- ClinicalTrials.gov ID
- NCT04864197
- Acronym / sponsor ID
- U0005B2O
- Conditions
- Thickening; Gingival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 28 Apr 2021 (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.
we used prf with dental implant treatment to find out whether prf has an effect on increasing the soft tissue thickness and keratinized tissue width
Detailed description
Clinical oral implant related research is facing many interesting challenges. One of them is to create and maintain stable soft and hard tissues around osseointegrated oral implants.
It was suggested in a classic study that a minimum of 2 mm of keratinized mucosa (KM) around natural teeth is necessary to maintain gingival health. The lack of a sufficient wide zone of KM has been investigated as a potential contributing factor for peri- implant disease and therefore might influence the long- term success of oral implants.
Various studies have found a negative influence of the absence of KM on plaque accumulation. Oral implants with a narrow zone of KM (<2 mm) frequently exhibit significantly higher plaque scores than those with wider zones of KM. Even a subdivision can be made between KM and attached KM (AKM). A statistically significant higher plaque accumulation and gingival inflammation around implants in the groups with KM <2 mm and AKM <1 mm was observed. However, this could not be confirmed in another study.
Interestingly, the presence of an adequate band of KM adjacent to the implant seems to reduce inflammation, hyperplasia and recession of the marginal peri- implant soft tissues. Furthermore, it might facilitate restorative procedures, improve aesthetics and enable the patient to maintain an adequate oral hygiene without irritation or discomfort.
In particular, in the lower jaw, a scarce amount of KM can be regularly encountered. A reduced height of the alveolar process, due to crestal bone resorption, result in loss of KM due to the reduced distance between the bone crest and "genetically defined" position of the mucogingival line. Notably, in the posterior segments of the lower jaw, a narrow KM might be related to muscle pull, high frenulum attachments and a shallow vestibule.
Today, the golden standard to augment KM is a free gingival graft (FGG) harvested from the palate. The main problem with this technique is the morbidity for the patient as it involves a second surgical site. Reported problems following FGG procedure are pain, change in diet, paresthesia, herpetic lesion, mucocele, arteriovenous shunt and excessive bleeding.
To overcome this problem, different authors have proposed alternative techniques and materials to augment keratinized tissue around teeth and oral implants.
Various studies have substantiated the viability of platelet concentrates on enhancement of osseous and associated tissue healing and PRF is one of the recent innovations of various platelet concentrates.
Platelet- rich fibrin (PRF) is a 2nd generation platelet concentrate, which was introduced by Choukroun et al in 2001. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Its 3- dimensional fibrin network promotes neovascularization, accelerates wound closing and fast cicatricle tissue remodeling. Platelet concentrates are considered a source of autologous growth factors that promote cell migration and proliferation. Given that PRF is produced without using any additive, the fibrin polymerization occurs in a physiological way, resulting in a similar fibrin network as the one formed during natural healing.
Studies show a constant release of growth factors such as PDGF (platelet-derived growth factor) or TGF-b (transforming growth factor) for at least 1 week up to 28 days and proved its accelerating effect on the healing process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prf group | Experimental | Biological: platelet rich fibrinprf membrane placement over implant site for gingival thickening |
| control group | Experimental | Biological: platelet rich fibrinno prf placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients greater than 18 years old without systemic diseases and having good oral hygiene (with D1-D3 bone density).
Key exclusion criteria (6 listed)
- general contraindications to implant surgery.
- patients with a history of severe periodontitis.
- bone augmentation required.
- smokers.
- treated or under treatment with intravenous aminobisphosphonates.
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 fibrinAlso: PRFprf membrane placement over implant site for gingival thickening | Biological | control group, prf group |
Primary outcome
measuring gingival thickness
Time frame: 6 months
transgingival measurement my endodontic reamer and then using digital vernier to determine the thickness
1 secondary outcome
keratinized tissue width
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 28 Apr 2021.
- 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.
Zaid M Yasser, M.S.c contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing platelet rich fibrin in people with Thickening; Gingival, run by University of Baghdad at 1 site in Iraq.
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 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 28 Apr 2021. 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 Iraq. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hussain F Fakhr Aldeen, B.D.S (07725228696, dentisth8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring gingival thickness (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 28 Apr 2021.