Immediate Implant Soft Tissue HealingNCT05517733
ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER
A study testing Platelet Rich Fibrin and Diode laser in people with Immediate Implant Soft Tissue Healing, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Immediate Implant Soft Tissue Healing
- What is being tested?
- Platelet Rich Fibrin and Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2021to 30 Jun 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
- Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
- No signs of active periodontal disease in the selected tooth.
- Good oral hygiene
Who cannot join
- The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
- The presence of Acute periapical infection.
- The presence of any local factor that may interfere with extraction as tooth ankyloses
- Subjects who had undergone therapeutical radiation. (187)
- Patients who had been subjected to or who were under bisphosphonate therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.
- Conditions
- Immediate Implant Soft Tissue Healing
- Being tested
- Platelet Rich Fibrin, Diode laser
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
for the preparation of PRF, A well-trained professional nurse drew 10ml of patient blood from the antecubital vein and transferred it to a test tube without anticoagulant. The blood sample was immediately centrifuged for 10-12 minutes at 3000 rpm. L-PRF was ready to use after centrifugation.
PRF membrane was put over the implant and slightly tucked under the soft tissue periphery, then held in place with a figure-of-8 suture by 0.5 proline suture
Diode laserDevice
- A 980 nm diode laser device (BIOLASE) was applied in a circular motion to the blood formed at the socket orifice at a power of 1W for 1 minute with a continuous wave mode, the application was done without touching the pooling blood and with a non-activated tip of the fiber optic.
- The laser application cycle was repeated 3-5 times to yield a stable fixed blood clot covering the dental implant with no oozing blood from its periphery.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin (PRF) | Experimental | Not described Receives: Biological: Platelet Rich Fibrin |
| Diode laser | Experimental | Not described Receives: Device: Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
This was done using Landry healing index. It evaluates the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration. The score ranges from 1 (Very poor) to 5 (Excellent).
Measured: up to 4 weeks
Mid-buccal soft tissue thickness
Measured from the gingival margin to implant platform using a periodontal probe.
Measured: up to 8 weeks
Mid-crestal soft tissue height
Measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw.
Measured: up to 8 weeks
Secondary outcomes (1)
Post-operative pain level
This was measured using the Visual Analogue Scale (VAS) that rates pain level on a scale of 0-10 (with 0 meaning no pain at all and 100 meaning the worst possible pain). A VAS questionnaire was given to the subjects and they were asked to select their pain score.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start10 Jun 2021
- Primary completion20 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant Soft Tissue HealingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517733
- Sponsor's protocol ID
- 11
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER (A RANDOMIZED CONTROLLED CLINICAL TRIAL)
- ClinicalTrials.gov ID
- NCT05517733
- Acronym / sponsor ID
- 11
- Conditions
- Immediate Implant Soft Tissue Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Aug 2022 (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.
Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin (PRF) | Experimental | Biological: Platelet Rich Fibrin |
| Diode laser | Experimental | Device: Diode laser |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
- Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
- No signs of active periodontal disease in the selected tooth.
- Good oral hygiene
Key exclusion criteria (5 listed)
- The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
- The presence of Acute periapical infection.
- The presence of any local factor that may interfere with extraction as tooth ankyloses
- Subjects who had undergone therapeutical radiation. (187)
- Patients who had been subjected to or who were under bisphosphonate therapy
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: PRFfor the preparation of PRF, A well-trained professional nurse drew 10ml of patient blood from the antecubital vein and transferred it to a test tube without anticoagulant. The blood sample was immediately centrifuged for 10-12 minutes at 3000 rpm. L-PRF was ready to use after centrifugation. PRF membrane was put over the implant and slightly tucked under the soft tissue periphery, then held in place with a figure-of-8 suture by 0.5 proline suture | Biological | Platelet Rich Fibrin (PRF) |
| Diode laser* A 980 nm diode laser device (BIOLASE) was applied in a circular motion to the blood formed at the socket orifice at a power of 1W for 1 minute with a continuous wave mode, the application was done without touching the pooling blood and with a non-activated tip of the fiber optic. * The laser application cycle was repeated 3-5 times to yield a stable fixed blood clot covering the dental implant with no oozing blood from its periphery. | Device | Diode laser |
Primary outcome
Soft tissue healing
Time frame: up to 4 weeks
This was done using Landry healing index. It evaluates the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration. The score ranges from 1 (Very poor) to 5 (Excellent).
Mid-buccal soft tissue thickness
Time frame: up to 8 weeks
Measured from the gingival margin to implant platform using a periodontal probe.
Mid-crestal soft tissue height
Time frame: up to 8 weeks
Measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw.
1 secondary outcome
Post-operative pain level
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
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 Diode laser in people with Immediate Implant Soft Tissue Healing, run by Nourhan M.Aly 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 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: finished, as of the sponsor's last update on 26 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Soft tissue healing (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. 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 26 Aug 2022.