Fractured ToothNCT04101552
Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
A study testing socket shield technique with xenophobic graft particulate and without the use of graft in people with Fractured Tooth, run by Cairo University.
Trial summary
Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fractured Tooth
- What is being tested?
- socket shield technique with xenophobic graft particulate and without the use of graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2019to 20 Aug 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Who cannot join
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Uncontrolled diabetic patients.
- Pregnant patients.
- Teeth with Large pulpal pathosis as cysts, large periapical granulomas
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
- Psychiatric problems.
Trial locations and contacts
No sites are listed yet.
Mohamed A. Abdelrasoul, lecturer contact
About this study
Official title: Clinical and Radiographic Assessment of Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique With and Without the Use of Xenograft Particulate Graft Material
Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions .
Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching.
However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.
Read the detailed description
- The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient
- Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
- Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
- In the study group: along surgical fissure bur will be used for hemisectioning.
- The palatal portion will be carefully separated and extracted by a periotome and forceps.
- The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment.
- The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration.
- In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone.
- The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap
- The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy
- A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.
- Conditions
- Fractured Tooth
- Being tested
- socket shield technique with xenophobic graft particulate and without the use of graft
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket shield technique with xenophobic graft particulate and without the use of graftProcedure or surgery
the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted
| Study group | Role | What they receive |
|---|---|---|
| grafted versus graft less socket shield technique | Experimental | Not described Receives: Procedure: socket shield technique with xenophobic graft particulate and without the use of graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Will be measured using linear measurements from CBCT
Measured: • Amount of bone loss will be measured after 6 month using linear measurement from CBCT
Secondary outcomes (1)
secondary stability
Will be measured using Osstell
Measured: will be measured intraoperative and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start20 Sep 2019 (estimated)
- Primary completion20 Feb 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractured ToothStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poosy Hany Zaki Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101552
- Sponsor's protocol ID
- PER-6-3-2
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique With and Without the Use of Xenograft Particulate Graft Material
- ClinicalTrials.gov ID
- NCT04101552
- Acronym / sponsor ID
- PER-6-3-2
- Conditions
- Fractured Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2019 (estimated)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 24 Sep 2019 (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.
Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions .
Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching.
However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.
Detailed description
- The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization.
- Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
- Intra operative procedures (for both groups) followed by CBCT will be taken for every patient
- Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
- Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
- In the study group: along surgical fissure bur will be used for hemisectioning.
- The palatal portion will be carefully separated and extracted by a periotome and forceps.
- The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment.
- The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration.
- In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone.
- The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap
- The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy
- A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grafted versus graft less socket shield technique | Experimental | Procedure: socket shield technique with xenophobic graft particulate and without the use of graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Key exclusion criteria (8 listed)
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Uncontrolled diabetic patients.
- Pregnant patients.
- Teeth with Large pulpal pathosis as cysts, large periapical granulomas
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 |
|---|---|---|
| socket shield technique with xenophobic graft particulate and without the use of graftthe jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted | Procedure or surgery | grafted versus graft less socket shield technique |
Primary outcome
Marginal bone loss
Time frame: • Amount of bone loss will be measured after 6 month using linear measurement from CBCT
Will be measured using linear measurements from CBCT
1 secondary outcome
secondary stability
Time frame: will be measured intraoperative and 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed A. Abdelrasoul, lecturer contact
Questions about this trial
What is this clinical trial studying?
A study testing socket shield technique with xenophobic graft particulate and without the use of graft in people with Fractured Tooth, 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 8 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 24 Sep 2019. 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 Poosy H. Mohamed, principal investigator (01098008064 ext. 00202, pussy_hany@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: • Amount of bone loss will be measured after 6 month using linear measurement from CBCT). 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 24 Sep 2019.