Tooth SocketNCT05437744
Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue
A study testing Cyanoacrylate glue and Platelet-rich fibrin (PRF) in people with Tooth Socket, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Socket
- What is being tested?
- Cyanoacrylate glue and Platelet-rich fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2021to 1 Aug 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, a Tooth with failed endodontic treatment, and tooth 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 graft
- A good standard of oral hygiene.
- No signs of active periodontal disease in the selected tooth.
Who cannot join
- The presence of any systemic disease that 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. (38)
- 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 Cyanoacrylate Glue (a Randomized Controlled Clinical Trial)
The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Study objective is to clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.
Read the detailed description
the study will be conducted on 16 extraction sockets in humans. Sockets will be randomly divided into two groups: Group I (test) will comprise 8 sockets sealed by PRF after immediate implant placement. Group II: (test) will comprise 8 sockets sealed by cyanoacrylate glue after immediate implant placement
- Conditions
- Tooth Socket
- Being tested
- Cyanoacrylate glue, Platelet-rich fibrin (PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate glueOther
8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue.
Platelet-rich fibrin (PRF)Other
8 sockets that will be treated by immediate implant placement and sealed by PRF.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Other: Cyanoacrylate glue |
| Control group | Active comparator | Not described Receives: Other: Platelet-rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in soft tissue healing
Soft tissue healing will be assessed in both groups in reference to the soft tissue healing index according to Landry index Landry index scores
Very poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with loss of epithelium beyond incision marginSuppuration: Present
Poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with connective tissue exposed
Good: Tissue colour: ≥25% and<50% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed
Very good: Tissue colour: <25% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed
Excellent: Tissue color: All tissues pinkResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed
Measured: at 2nd week and 4th week
Change in Mid crestal soft tissue thickness
Mid crestal soft tissue thickness over the immediate implant will be 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, after 4 weeks postoperatively
Measured: at baseline and after 4 weeks
change in Mid-buccal soft tissue height
Mid-buccal soft tissue height: will be measured from gingival margin to implant platform, at surgery time and 4 weeks postoperatively
Measured: at baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start12 Dec 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth SocketStudies 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
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437744
- Sponsor's protocol ID
- Cyanoacrylates_2021
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 29 Jun 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 29 Jun 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 Cyanoacrylate Glue (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05437744
- Acronym / sponsor ID
- Cyanoacrylates_2021
- Conditions
- Tooth Socket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 29 Jun 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.
The health of peri-implant soft tissues is one of the most important aspects necessary for the long-term survival of dental implants. The importance of the peri-implant mucosal region lies in the need to establish a tight seal that isolates the implant and the bone from the oral environment. Study objective is to clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.
Detailed description
the study will be conducted on 16 extraction sockets in humans. Sockets will be randomly divided into two groups: Group I (test) will comprise 8 sockets sealed by PRF after immediate implant placement. Group II: (test) will comprise 8 sockets sealed by cyanoacrylate glue after immediate implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Cyanoacrylate glue |
| Control group | Active comparator | Other: Platelet-rich fibrin (PRF) |
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, a Tooth with failed endodontic treatment, and tooth 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 graft
- A good standard of oral hygiene.
- No signs of active periodontal disease in the selected tooth.
Key exclusion criteria (5 listed)
- The presence of any systemic disease that 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. (38)
- 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 |
|---|---|---|
| Cyanoacrylate glue8 sockets that will be treated by immediate implant placement and sealed by a Cyanoacrylate glue. | Other | Study group |
| Platelet-rich fibrin (PRF)8 sockets that will be treated by immediate implant placement and sealed by PRF. | Other | Control group |
Primary outcome
Change in soft tissue healing
Time frame: at 2nd week and 4th week
Soft tissue healing will be assessed in both groups in reference to the soft tissue healing index according to Landry index Landry index scores Very poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with loss of epithelium beyond incision marginSuppuration: Present Poor: Tissue color: ≥50% of gingiva red Response to palpation: BleedingGranulation tissue: PresentIncision margin: Not epithelialized, with connective tissue exposed Good: Tissue colour: ≥25% and<50% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Very good: Tissue colour: <25% of gingiva redResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed Excellent: Tissue color: All tissues pinkResponse to palpation: No bleedingGranulation tissue: NoneIncision margin: No connective tissue exposed
Change in Mid crestal soft tissue thickness
Time frame: at baseline and after 4 weeks
Mid crestal soft tissue thickness over the immediate implant will be 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, after 4 weeks postoperatively
change in Mid-buccal soft tissue height
Time frame: at baseline and after 4 weeks
Mid-buccal soft tissue height: will be measured from gingival margin to implant platform, at surgery time and 4 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
Related trials for Tooth Socket
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
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 Cyanoacrylate glue and Platelet-rich fibrin (PRF) in people with Tooth Socket, run by Hams Hamed Abdelrahman 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: status not confirmed, as of the sponsor's last update on 29 Jun 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?
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?
Change in soft tissue healing (time frame: at 2nd week and 4th week). 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 29 Jun 2022.