Badly Decayed Upper Anterior TeethNCT03696862
Assessment of Collagen Plug for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
A study testing free gingival graft in people with Badly Decayed Upper Anterior Teeth, run by Cairo University.
Trial summary
Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Badly Decayed Upper Anterior Teeth
- What is being tested?
- free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to Sep 2019
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Who cannot join
- Uncontrolled periapical infections
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone.
It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling.
Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar bone.
Read the detailed description
Alveolar socket preservation using primary flap closure technique utilizing free gingival graft in conjunction with bone substitutes didn't produce the desired effect on ridge preservation compared with bone substitutes alone. A clinical trial showed that achieving primary closure didn't present additional beneficial effect on preserving ridge width, however, the mucosa was significantly thicker and more coronally positioned.
Also soft tissue graft has its limitations on covering graft material and socket preservation due to the higher morbidity given that the soft tissue graft has to be harvested from a donor site of the patient.
Another options for socket seal are coronal advancement of buccal flap or rotating grafts from tissue adjacent to cover the defect but they have limitations such as altering the mucogingival line and creating a shallow vestibule.
Lekovic et al. investigated the use of a non-resorbable polytetrafluroethylene membrane but it was found also to have its limitations as 30% of the membranes became exposed and as a result loss of bone height and width occurred.
Also studies have found that using bone substitutes together with collagen membrane with primary closure of the socket has shown clear effects on preserving alveolar ridge height as well as ridge width, however, its limitation are flap dehiscence and subsequent membrane exposure and the increased cost.
- Conditions
- Badly Decayed Upper Anterior Teeth
- Being tested
- free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free gingival graftProcedure or surgery
Use of free gingival graft to seal the socket after flapless atraumatic tooth extraction is performed, implant placement and filling the socket with bone graft.
| Study group | Role | What they receive |
|---|---|---|
| collagen plug | Experimental | collagen plug used to seal the socket after atraumatic extraction of the badly deacayed teeth with immediate implant placement and bone graft Receives: Procedure: free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in soft tissue
soft tissue changes will be measured in millimeters clinically and on a cast before and after the procedure
Measured: 3 month
changes in bone
bone loss and gain will be measured in millimeters using cone beam computed tomography before and after the procedure
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Decayed Upper Anterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara elsandouby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696862
- Sponsor's protocol ID
- CairoUimplant master porgram
- Status last verified
- Oct 2018
- First submitted
- 16 Sep 2018
- Last updated
- 5 Oct 2018
- 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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT03696862
- Acronym / sponsor ID
- CairoUimplant master porgram
- Conditions
- Badly Decayed Upper Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Oct 2018 (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.
Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone.
It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling.
Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar bone.
Detailed description
Alveolar socket preservation using primary flap closure technique utilizing free gingival graft in conjunction with bone substitutes didn't produce the desired effect on ridge preservation compared with bone substitutes alone. A clinical trial showed that achieving primary closure didn't present additional beneficial effect on preserving ridge width, however, the mucosa was significantly thicker and more coronally positioned.
Also soft tissue graft has its limitations on covering graft material and socket preservation due to the higher morbidity given that the soft tissue graft has to be harvested from a donor site of the patient.
Another options for socket seal are coronal advancement of buccal flap or rotating grafts from tissue adjacent to cover the defect but they have limitations such as altering the mucogingival line and creating a shallow vestibule.
Lekovic et al. investigated the use of a non-resorbable polytetrafluroethylene membrane but it was found also to have its limitations as 30% of the membranes became exposed and as a result loss of bone height and width occurred.
Also studies have found that using bone substitutes together with collagen membrane with primary closure of the socket has shown clear effects on preserving alveolar ridge height as well as ridge width, however, its limitation are flap dehiscence and subsequent membrane exposure and the increased cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| collagen plug | Experimental | Procedure: free gingival graftcollagen plug used to seal the socket after atraumatic extraction of the badly deacayed teeth with immediate implant placement and bone graft |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (6 listed)
- Uncontrolled periapical infections
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
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 |
|---|---|---|
| free gingival graftUse of free gingival graft to seal the socket after flapless atraumatic tooth extraction is performed, implant placement and filling the socket with bone graft. | Procedure or surgery | collagen plug |
Primary outcome
changes in soft tissue
Time frame: 3 month
soft tissue changes will be measured in millimeters clinically and on a cast before and after the procedure
changes in bone
Time frame: 6 month
bone loss and gain will be measured in millimeters using cone beam computed tomography before and after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing free gingival graft in people with Badly Decayed Upper Anterior Teeth, run by Cairo University.
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 6 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 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sara MR Elsandouby, bachelor's (01281106660, saraelsandouby@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in soft tissue (time frame: 3 month). The study lists 2 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 5 Oct 2018.