Badly Broken Maxillary Premolars Indicated for ExtractionNCT06835543
Soft Tissue Healing After Tooth Extraction
A study testing Amnion membrane. and Chorion membrane 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: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions. Read more about this study
- Who is it for?
- Ages 20 to 45 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?
- Amnion membrane. and Chorion membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients who need simple extraction not indicated for immediate implant placement.
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, 123456
About this study
Official title: Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial
Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
Read the detailed description
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. 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
- Amnion membrane., Chorion membrane
- Keywords
- Amnion membrane, chorion membrane, soft tissue healing, tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion membrane.Procedure or surgery
the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material
Chorion membraneProcedure or surgery
chorion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 4-0 resorbable suture material.
| Study group | Role | What they receive |
|---|---|---|
| Amnion membrane | Active comparator | the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material Receives: Procedure: Amnion membrane. |
| Chorion membrane. | Active comparator | chorion membrane (Bioxclude , Snoasis Medical , USA) tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. Receives: Procedure: Chorion membrane |
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: every day for the first week, day after day second week, once in third and fourth week
Secondary outcomes (1)
Healing index
Score (from o to 10, were 0 is no healing and 10 complete healing of tissue )
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 posted19 Feb 2025
- Study start7 Jan 2025
- Primary completion7 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.
- 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
- 190 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
- NCT06835543
- Sponsor's protocol ID
- soft tissue healing
- 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
- Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06835543
- Acronym / sponsor ID
- soft tissue healing
- Keywords
- Amnion membrane, chorion membrane, soft tissue healing, tooth extraction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Jul 2025 (estimated)
- Study completion
- 1 Aug 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: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
Detailed description
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. 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 |
|---|---|---|
| Amnion membrane | Active comparator | Procedure: Amnion membrane.the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material |
| Chorion membrane. | Active comparator | Procedure: Chorion membranechorion membrane (Bioxclude , Snoasis Medical , USA) tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Patients who need simple extraction not indicated for immediate implant placement.
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 |
|---|---|---|
| Amnion membrane.the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material | Procedure or surgery | Amnion membrane |
| Chorion membranechorion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 4-0 resorbable suture material. | Procedure or surgery | Chorion membrane. |
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
1 secondary outcome
Healing index
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 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 Amnion membrane. and Chorion membrane 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 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 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: 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.