Estetic ZoneNCT05431998
Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone.
A study testing the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement and the use of autogenous bone graft in the jumping gap during immediate implant placement in people with Estetic Zone and Autogenous Tooth Graft, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Estetic Zone, Autogenous Tooth Graft, Autogenous Bone Graft
- What is being tested?
- the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement and the use of autogenous bone graft in the jumping gap during immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Aug 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in need of extraction of a single, un-restorable tooth in the esthetic zone (Maxillary anteriors and premolars). Only one implant per patient.
- An intact buccal plate of bone, or minimally affected. Jumping gap ≥ 2mm . Age 18-60. Medically free patients.
Who cannot join
- Restorable teeth. Teeth with severely damaged or no remaining buccal plate. Acute infection in the implant site. Patients with an insufficient bone to obtain primary stability. Patients in need of sinus bone grafting. A systemic condition that affects bone healing (e.g., diabetes mellitus or bone disease).
- Smokers. Poor oral hygiene. Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Any general contraindication to oral surgery. Participants suffering from diseases that may affect bone or soft tissue healing.
- A participant who had radiotherapy or chemotherapy. Psychiatric patient, or with a learning disability, or unable to give consent. Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Ciaro University
Cairo, El Manial, 4240101
Nesma M Shemais, PhD, Nesma.Shemais@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. (Randomized Controlled Clinical Trial).
To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading.
Read the detailed description
Immediate implant placement was introduced in 1978, using a ceramic implant made of Al2O3. Ever since then it has become one of the most successful treatment options to maintain the alveolar bone after tooth extraction, showing success rate of more than 95%. Continuous research and development of immediate implant techniques keep being introduced, stemming from the fact that immediate implant placement is a safe, predictable, and favorable solution after the loss of a tooth.
A 2 mm jumping gap is recommended in the treatment guidelines proposed in an ITI Consensus Conference. This provides sufficient space to fill the bone defect between the exposed implant surface and the facial bone wall with an appropriate bone filler. A gap in these dimensions also provides a space for the formation of a blood clot which can subsequently reorganize into a provisional connective tissue matrix and support the formation of newly formed woven bone. This was demonstrated in a preclinical study in which a wider defect and bone wall dimension were associated with less crestal bone height reduction and more bone to implant contact than a narrower defect and bone wall dimension. Also, immediate placement with a dual-zone augmentation technique, and a socket seal technique utilizing a prefabricated shell made of acrylic and immediate restoration, out of occlusion showed very promising results.
The addition of graft material during immediate implant placement is very common and useful in many cases. Autogenous bone graft is considered to be the gold standard graft material, which makes comparing new graft materials to it sensible. Still, tooth bone graft has been used numerous of times for socket preservation, and it shows good results.
- Conditions
- Estetic Zone, Autogenous Tooth Graft, Autogenous Bone Graft, Immediate Implant, Jumping Gap, Crestal Bone Level
- Being tested
- the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement, the use of autogenous bone graft in the jumping gap during immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placementProcedure or surgery
the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement
the use of autogenous bone graft in the jumping gap during immediate implant placementProcedure or surgery
the use of autogenous bone graft in the jumping gap during immediate implant placement
| Study group | Role | What they receive |
|---|---|---|
| The use of demineralized autogenous tooth graft in the jumping gap of the immediate implant | Experimental | The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high-speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill (Gold Bone Mill, MCT Bio, Korea). Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid (Chemajet Chemicals, Egypt) for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the bone defect around the immediately placed implant. Receives: Procedure: the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement |
| The use of autogenous bone graft in the jumping gap of the immediate implant | Active comparator | A horizontal vestibular incision will be placed below the mucogingival junction and a mucoperiosteal flap will be reflected then autogenous bone particles will be collected from the participants using Automatic Bone Collector Bur (ACM Bur) by NeoBiotch, from the mandibular retro-molar region, speed 300rpm, torque 30Ncm, with irrigation. Receives: Procedure: the use of autogenous bone graft in the jumping gap during immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level
Marginal bone level: The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces (mesial, distal, buccal, and lingual/palatal), measured by CBCT scans.
Measured: 9 months
Secondary outcomes (3)
post operative pain
Visual analog scale (0-10)
Measured: 2 weeks
Implant sucess
Based on the criteria of Albrektsson, Zarb, Worthington, and Eriksson(1986) and of Buser, Weber and Lang(1990). The following are the criteria for implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as a failure if they can't reach any one of the success criteria
Measured: 12 months
Pink esthetic score
The PES includes seven variables: the mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color, and soft tissue texture. Each variable was evaluated with a 0-1-2 score, with 2 being the best and 0 being the worst. Thus, the highest total score was 14. The mesial and distal papillae were assessed for completeness. All other variables were evaluated by comparison with the contralateral tooth. The threshold of an acceptable PES was 8. Scores of 12 or more indicated a nearly perfect outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estetic ZoneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Taha Taha Ahmed, Cairo University
- Investigators
- Karim M Fawzy, PhD, Study chair, Cairo UniversityNesma M Shemais, PhD, Study director, Cairo UniversityRahma H Ahmed, BDS, Principal investigator, Cairo UniversityAhmed T Taha, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431998
- Sponsor's protocol ID
- At1
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone. (Randomized Controlled Clinical Trial).
- ClinicalTrials.gov ID
- NCT05431998
- Acronym / sponsor ID
- At1
- Conditions
- Estetic Zone, Autogenous Tooth Graft, Autogenous Bone Graft, Immediate Implant, Jumping Gap, Crestal Bone Level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 24 Jun 2022 (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.
To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading.
Detailed description
Immediate implant placement was introduced in 1978, using a ceramic implant made of Al2O3. Ever since then it has become one of the most successful treatment options to maintain the alveolar bone after tooth extraction, showing success rate of more than 95%. Continuous research and development of immediate implant techniques keep being introduced, stemming from the fact that immediate implant placement is a safe, predictable, and favorable solution after the loss of a tooth.
A 2 mm jumping gap is recommended in the treatment guidelines proposed in an ITI Consensus Conference. This provides sufficient space to fill the bone defect between the exposed implant surface and the facial bone wall with an appropriate bone filler. A gap in these dimensions also provides a space for the formation of a blood clot which can subsequently reorganize into a provisional connective tissue matrix and support the formation of newly formed woven bone. This was demonstrated in a preclinical study in which a wider defect and bone wall dimension were associated with less crestal bone height reduction and more bone to implant contact than a narrower defect and bone wall dimension. Also, immediate placement with a dual-zone augmentation technique, and a socket seal technique utilizing a prefabricated shell made of acrylic and immediate restoration, out of occlusion showed very promising results.
The addition of graft material during immediate implant placement is very common and useful in many cases. Autogenous bone graft is considered to be the gold standard graft material, which makes comparing new graft materials to it sensible. Still, tooth bone graft has been used numerous of times for socket preservation, and it shows good results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The use of demineralized autogenous tooth graft in the jumping gap of the immediate implant | Experimental | Procedure: the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placementThe participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high-speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill (Gold Bone Mill, MCT Bio, Korea). Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid (Chemajet Chemicals, Egypt) for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the bone defect around the immediately placed implant. |
| The use of autogenous bone graft in the jumping gap of the immediate implant | Active comparator | Procedure: the use of autogenous bone graft in the jumping gap during immediate implant placementA horizontal vestibular incision will be placed below the mucogingival junction and a mucoperiosteal flap will be reflected then autogenous bone particles will be collected from the participants using Automatic Bone Collector Bur (ACM Bur) by NeoBiotch, from the mandibular retro-molar region, speed 300rpm, torque 30Ncm, with irrigation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients in need of extraction of a single, un-restorable tooth in the esthetic zone (Maxillary anteriors and premolars). Only one implant per patient.
- An intact buccal plate of bone, or minimally affected. Jumping gap ≥ 2mm . Age 18-60. Medically free patients.
Key exclusion criteria (4 listed)
- Restorable teeth. Teeth with severely damaged or no remaining buccal plate. Acute infection in the implant site. Patients with an insufficient bone to obtain primary stability. Patients in need of sinus bone grafting. A systemic condition that affects bone healing (e.g., diabetes mellitus or bone disease).
- Smokers. Poor oral hygiene. Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Any general contraindication to oral surgery. Participants suffering from diseases that may affect bone or soft tissue healing.
- A participant who had radiotherapy or chemotherapy. Psychiatric patient, or with a learning disability, or unable to give consent. Pregnant and nursing women
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 |
|---|---|---|
| the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placementthe use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement | Procedure or surgery | The use of demineralized autogenous tooth graft in the jumping gap of the immediate implant |
| the use of autogenous bone graft in the jumping gap during immediate implant placementthe use of autogenous bone graft in the jumping gap during immediate implant placement | Procedure or surgery | The use of autogenous bone graft in the jumping gap of the immediate implant |
Primary outcome
Marginal bone level
Time frame: 9 months
Marginal bone level: The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces (mesial, distal, buccal, and lingual/palatal), measured by CBCT scans.
3 secondary outcomes
post operative pain
Time frame: 2 weeks
Implant sucess
Time frame: 12 months
Pink esthetic score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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.
Karim M Fawzy, PhD study chair
Cairo University
Nesma M Shemais, PhD study director
Cairo University
Rahma H Ahmed, BDS principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement and the use of autogenous bone graft in the jumping gap during immediate implant placement in people with Estetic Zone and Autogenous Tooth Graft, run by Cairo 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 2 inclusion and 4 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 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed T Taha, BDS (00201026776111, ahmed-taha@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone level (time frame: 9 months). 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 Jun 2022.