Immediate ImplantNCT05891990
Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence
A study testing immediate implant augmented with sticky tooth and immediate implant augmented with autogenous tooth graft in people with Immediate Implant, run by Halla Gamal Mohammed Esmail.
Trial summary
Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant
- What is being tested?
- immediate implant augmented with sticky tooth and immediate implant augmented with autogenous tooth graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Dec 2025
- 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
- Non-restorable teeth in the esthetic zone with a defect of labial bone.
- Teeth with no acute inflammation.
- Patients are free from any systemic condition that may affect the healing.
- Availability of bone apical and palatal to the socket to provide primary stability
- Good oral health.
- Willingness to sign the informed consent form.
Who cannot join
- Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- Acute inflammation in the site of implantation and adjacent tissue.
- A history of radiotherapy in the head or neck region.
- Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation
About this study
Official title: Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence
Read the detailed description
In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant
- Conditions
- Immediate Implant
- Being tested
- immediate implant augmented with sticky tooth, immediate implant augmented with autogenous tooth graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant augmented with sticky toothProcedure or surgery
- Topical anesthesia will be administered using an infiltration technique.
- Atraumatic extraction will be done with the aid of periotome and Luxators.
- The extraction socket will be debrided to remove any residual debris or granulation tissue.
- Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
- Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
- The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes.
- Finally, the flap will be repositioned and sutured.
immediate implant augmented with autogenous tooth graftProcedure or surgery
- Topical anesthesia will be administered using an infiltration technique.
- Atraumatic extraction will be done with the aid of periotome and Luxators.
- The extraction socket will be debrided to remove any residual debris or granulation tissue.
- Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
- Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
- The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes.
- Finally, the flap will be repositioned and sutured.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | sticky tooth preparation:
* patient's venous blood will be collected using a 21 g needle with a butterfly handle.
* The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit.
* The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth. Receives: Procedure: immediate implant augmented with sticky tooth |
| Control group | Active comparator | Autogenous demineralized dentin graft preparation
* Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation.
* The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles.
* The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer.
* Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix.
* After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze. Receives: Procedure: immediate implant augmented with autogenous tooth graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic width of bone labial to the implant
Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times
Measured: 1 year
Secondary outcomes (10)
Radiographic horizontal bucco-palatal bone changes
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the coronal width (CW), middle width (MW), and apical width (AW). Each measurement will be recorded at different times
Measured: 1 year
Radiographic vertical bone changes
Vertical bone height will be measured. Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. Each measurement will be recorded at different times and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension
Measured: 1 year
Esthetic evaluation (The pink esthetic score)
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
Measured: 1 year
Implant stability
Implant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
Measured: 6 months
Gingival Thickness
Gingival thickness will be evaluated 2 mm below the gingival margin with a short needle for and silicon disk stop. The needle will be inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was reached. The silicone disc stop was then mounted in close contact with the gingival tissue surface. The insertion depth was assessed with a digital caliper accurate to the nearest 0.1 mm
Measured: 1 year
Width of the Keratinized Tissue
It will be evaluated from the gingival margin to the mucogingival junction (MGJ). The MGJ was assessed with roll technique
Measured: 1 year
Midfacial recession
Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
Measured: 1 year
Post-Operative Pain
Pain will be assessed post-surgically using the Visual Analogue Scale (VAS) with numbers from 0 to 10 score zero represented no pain while score 10 represented the worst pain imaginable
Measured: 7 days
Post-Operative patient's Satisfaction
Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
/
Measured: 1 year
Post-operative swelling
Swelling will be assessed post-surgically using the Verbal Rating Scale (VRS) (García et al. 2008):
- Absent (no swelling),
- Slight (intraoral swelling at the operated area),
- Moderate (moderate intraoral swelling at the operated area) and
- Intense (intensive extraoral swelling extending beyond the operated area)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halla Gamal Mohammed Esmail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halla Gamal Mohammed Esmail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891990
- Sponsor's protocol ID
- 2023
- Status last verified
- Sep 2023
- First submitted
- 27 May 2023
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05891990
- Acronym / sponsor ID
- 2023
- Conditions
- Immediate Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Halla Gamal Mohammed EsmailUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Jun 2023 (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.
Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence
Detailed description
In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: immediate implant augmented with sticky toothsticky tooth preparation: * patient's venous blood will be collected using a 21 g needle with a butterfly handle. * The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit. * The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth. |
| Control group | Active comparator | Procedure: immediate implant augmented with autogenous tooth graftAutogenous demineralized dentin graft preparation * Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. * The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles. * The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer. * Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix. * After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-restorable teeth in the esthetic zone with a defect of labial bone.
Key exclusion criteria (7 listed)
- Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- Acute inflammation in the site of implantation and adjacent tissue.
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 |
|---|---|---|
| immediate implant augmented with sticky tooth* Topical anesthesia will be administered using an infiltration technique. * Atraumatic extraction will be done with the aid of periotome and Luxators. * The extraction socket will be debrided to remove any residual debris or granulation tissue. * Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection. * Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability. * The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes. * Finally, the flap will be repositioned and sutured. | Procedure or surgery | Intervention group |
| immediate implant augmented with autogenous tooth graft* Topical anesthesia will be administered using an infiltration technique. * Atraumatic extraction will be done with the aid of periotome and Luxators. * The extraction socket will be debrided to remove any residual debris or granulation tissue. * Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection. * Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability. * The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes. * Finally, the flap will be repositioned and sutured. | Procedure or surgery | Control group |
Primary outcome
Radiographic width of bone labial to the implant
Time frame: 1 year
Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times
10 secondary outcomes
Radiographic horizontal bucco-palatal bone changes
Time frame: 1 year
Radiographic vertical bone changes
Time frame: 1 year
Esthetic evaluation (The pink esthetic score)
Time frame: 1 year
Implant stability
Time frame: 6 months
Gingival Thickness
Time frame: 1 year
Width of the Keratinized Tissue
Time frame: 1 year
Midfacial recession
Time frame: 1 year
Post-Operative Pain
Time frame: 7 days
Post-Operative patient's Satisfaction
Time frame: 1 year
Post-operative swelling
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant augmented with sticky tooth and immediate implant augmented with autogenous tooth graft in people with Immediate Implant, run by Halla Gamal Mohammed Esmail.
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 6 inclusion and 7 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 7 Sep 2023. 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?
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?
Radiographic width of bone labial to the implant (time frame: 1 year). 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 7 Sep 2023.