Badly Broken Maxillary Premolars Indicated for ExtractionNCT06834802
3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM
A study testing PRF, Human amniotic membrane and No grafting in people with Badly Broken Maxillary Premolars Indicated for Extraction and Badly Broken Down Vital Teeth, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function \& success. Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Badly Broken Maxillary Premolars Indicated for Extraction, Badly Broken Down Vital Teeth
- What is being tested?
- PRF, Human amniotic membrane and No grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients at least 18 years old, with non-restorable first and second molars.
- Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
- Minimum alveolar Bucco-palatal dimension of 7 mm.
Who cannot join
- Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
- Patients who are smokers.
- Presence of signs of active infection or pus formation.
- Absence or loss of buccal wall prior to implant placement.
- Bad oral hygiene
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of oral and dental medicine , Suez university
Cairo, Cairo Governorate, 123456
About this study
Official title: 3D Analysis of Soft Tissue Healing After Immediate Implant Placement in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study
Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function \& success.
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Read the detailed description
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
- Being tested
- PRF, Human amniotic membrane, No grafting
- Keywords
- jumping gap, immediate implant placemnet, soft tissue around implant, soft tissue healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFProcedure or surgery
PRF membrane will be used for soft tissue grafting around implant
Human amniotic membraneProcedure or surgery
Human amniotic membrane will be used for soft tissue grafting around implan
No graftingProcedure or surgery
No soft tissue grafting around implant
| Study group | Role | What they receive |
|---|---|---|
| Grafting with PRF | Active comparator | immediate implant will be placed and PRF membrane will be placed into the soft tissue. The PRF plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. Receives: Procedure: PRF |
| Grafting using Human amniotic membrane (HAM) | Active comparator | immediate implant placement will be done and The HAM plug will be placed into the soft tissue. Receives: Procedure: Human amniotic membrane |
| No Grafting | Active comparator | Immediate implant placement will be done and with no soft tissue grafting Receives: Procedure: No grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
Surface area/intraoral scanner
Measured: Baseline, every day for the first week, day after day second week, once in third and fourth week
Secondary outcomes (1)
post operative pain
Visual analog scale: numerical scale in which 0 is no pain and 10 is maximum pain
Measured: Baseline, every day for the first week, day after day second week, once in third and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start7 Jan 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Broken Maxillary Premolars Indicated for ExtractionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834802
- Sponsor's protocol ID
- 3D soft tissue assessment
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Analysis of Soft Tissue Healing After Immediate Implant Placement in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study in Molar Sites Using PRF Vs HAM: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06834802
- Acronym / sponsor ID
- 3D soft tissue assessment
- Keywords
- jumping gap, immediate implant placemnet, soft tissue around implant, soft tissue healing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Feb 2025 (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.
Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function \& success.
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Detailed description
Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grafting with PRF | Active comparator | Procedure: PRFimmediate implant will be placed and PRF membrane will be placed into the soft tissue. The PRF plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. |
| Grafting using Human amniotic membrane (HAM) | Active comparator | Procedure: Human amniotic membraneimmediate implant placement will be done and The HAM plug will be placed into the soft tissue. |
| No Grafting | Active comparator | Procedure: No graftingImmediate implant placement will be done and with no soft tissue grafting |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients at least 18 years old, with non-restorable first and second molars.
- Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
- Minimum alveolar Bucco-palatal dimension of 7 mm.
Key exclusion criteria (5 listed)
- Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
- Patients who are smokers.
- Presence of signs of active infection or pus formation.
- Absence or loss of buccal wall prior to implant placement.
- Bad oral hygiene
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 |
|---|---|---|
| PRFPRF membrane will be used for soft tissue grafting around implant | Procedure or surgery | Grafting with PRF |
| Human amniotic membraneHuman amniotic membrane will be used for soft tissue grafting around implan | Procedure or surgery | Grafting using Human amniotic membrane (HAM) |
| No graftingNo soft tissue grafting around implant | Procedure or surgery | No Grafting |
Primary outcome
Soft tissue healing
Time frame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Surface area/intraoral scanner
1 secondary outcome
post operative pain
Time frame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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 PRF, Human amniotic membrane and No grafting in people with Badly Broken Maxillary Premolars Indicated for Extraction and Badly Broken Down Vital Teeth, run by Ain Shams 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 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Baseline, every day for the first week, day after day second week, once in third and fourth week). 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 19 Feb 2025.