Badly Broken Maxillary Premolars Indicated for ExtractionNCT06927453
Soft Tissue Healing During Alveolar Ridge Preservation
A study testing Acrylic splint and No splint in people with Badly Broken Maxillary Premolars Indicated for Extraction, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Badly Broken Maxillary Premolars Indicated for Extraction
- What is being tested?
- Acrylic splint and No splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2025to 1 Aug 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Patients who need simple teeth extractions.
Who cannot join
- Patients with inability or anticipated failure to maintain adequate oral hygiene.
- Pregnant or breast-feeding mothers.
- Any medical condition or therapy that can affect healing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of oral and dental medicine , Suez university
Suez, Suez Governorate, 23568
About this study
Official title: Assessment of the Effect of Covered Versus Uncovered Human Amniotic Membrane In Soft Tissue Healing During Alveolar Ridge Preservation: A Randomized Controlled Trial
Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
Read the detailed description
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
materials and methods: Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. Soft tissue healing will be assessed (1ry outcome) 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
- Acrylic splint, No splint
- Keywords
- Human amniotic Membrane (HAM), Alveolar ridge preservation, Soft tissue healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrylic splintProcedure or surgery
The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint.
No splintProcedure or surgery
The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered
| Study group | Role | What they receive |
|---|---|---|
| Acrylic splint . | Active comparator | ●The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint. |
| No splint . | Active comparator | The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered by splint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
Surface area/intraoral Scanner in mm
Measured: 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 score ( score from 0 to 10 in which 0 is no pain and 10 is maximum pain )
Measured: 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 posted15 Apr 2025
- Study start7 Jan 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 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
- 48 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
- NCT06927453
- Sponsor's protocol ID
- Soft Tissue Healing
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2025
- Last updated
- 15 Apr 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Covered Versus Uncovered Human Amniotic Membrane In Soft Tissue Healing During Alveolar Ridge Preservation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06927453
- Acronym / sponsor ID
- Soft Tissue Healing
- Keywords
- Human amniotic Membrane (HAM), Alveolar ridge preservation, Soft tissue healing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Apr 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: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
Detailed description
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
materials and methods: Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. Soft tissue healing will be assessed (1ry outcome) 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Acrylic splint . | Active comparator | –●The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint. |
| No splint . | Active comparator | –The HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered by splint. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.Patients who need simple teeth extractions.
Key exclusion criteria (3 listed)
- Patients with inability or anticipated failure to maintain adequate oral hygiene.
- Pregnant or breast-feeding mothers.
- Any medical condition or therapy that can affect healing.
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 |
|---|---|---|
| Acrylic splintThe HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site covered with the custom acrylic splint. | Procedure or surgery | – |
| No splintThe HAM particulate material will be packed into the extraction socket then the HAM will be tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. The surgical site will not be covered | Procedure or surgery | – |
Primary outcome
Soft tissue healing
Time frame: every day for the first week, day after day second week, once in third and fourth week
Surface area/intraoral Scanner in mm
1 secondary outcome
post operative pain
Time frame: 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 15 Apr 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 Acrylic splint and No splint in people with Badly Broken Maxillary Premolars Indicated for Extraction, 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 1 inclusion and 3 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 15 Apr 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: 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 15 Apr 2025.