Immediate ImplantNCT05946954
Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence
A study testing Immediate Dentoalveolar Restoration and Ice cream cone technique in people with Immediate Implant, run by Aya Sharaf at 1 site in Egypt.
Trial summary
: Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique 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 Dentoalveolar Restoration and Ice cream cone technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jun 2026
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soft and Hard Tissue Changes Following Immediate Implant Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
: Evaluation of Soft and Hard Tissue Changes following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique 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 Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant
- Conditions
- Immediate Implant
- Being tested
- Immediate Dentoalveolar Restoration, Ice cream cone technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Dentoalveolar RestorationProcedure 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. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence.
- Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability
Ice cream cone techniqueProcedure 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. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence.
- Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability
| Study group | Role | What they receive |
|---|---|---|
| Intervention group Immediate Dentoalveolar Restoration | Experimental | * After applying anesthesia to the maxillary tuberosity, a full thickness crestal incision was made following the distal contour of the maxillary right second molar. This incision was followed by a palatal release incision to access the donor area.
* The flap was raised in the tuberosity area Then, the bone graft was harvested from the underlying bone by using a 1 cm wide flat chisel and a surgical hammer.
* The corticocancellous graft was manipulated using a rongeur to reproduce the shape of the peri-implant bone defect.
* The graft was carefully inserted to the level of the implant platform Finally, a screw-retained resin provisional crown, relined over a polyetheretherketone (PEEK) anti-rotation abutment, was placed out of occlusion, establishing the ideal emergence profile to accommodate the soft tissues and to promote a thicker and more stable gingival tissue margin Receives: Procedure: Immediate Dentoalveolar Restoration |
| Control group Ice cream cone technique | Active comparator | Ice cream cone technique
1. Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone.
2. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.
The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using resorbable sutures to prevent dislodgment of the blood clot and bone grafting material Receives: Procedure: Ice cream cone technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bucco/facial-palatal ridge thickness
Impressions were taken with addition silicone before tooth extraction, after six months of implant placement (immediately after the placement of the definite crown) and 12 months after crown installation. Casts were then obtained with special gypsum stone type IV.Casts were measured by a dentist not involved in the study with a digital caliper. Three reference points were measured from the free gingival margin to the apex at the implant site and in the contralateral tooth: 0 mm, 3 mm and 6 mm
Measured: 1 year
Secondary outcomes (11)
Radiographic 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
3. 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 (at day 0 after finishing the procedure, 6 and 12 months post-operatively)
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 posted14 Jul 2023
- Study start1 Oct 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Sharaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Sharaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946954
- Sponsor's protocol ID
- 2623
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2023
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft and Hard Tissue Changes Following Immediate Implant Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05946954
- Acronym / sponsor ID
- 2623
- Conditions
- Immediate Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aya SharafUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 14 Jul 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 following Immediate Implant using Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique 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 Immediate Dentoalveolar Restoration Versus Ice Cream Cone technique 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 Immediate Dentoalveolar Restoration | Experimental | Procedure: Immediate Dentoalveolar Restoration* After applying anesthesia to the maxillary tuberosity, a full thickness crestal incision was made following the distal contour of the maxillary right second molar. This incision was followed by a palatal release incision to access the donor area. * The flap was raised in the tuberosity area Then, the bone graft was harvested from the underlying bone by using a 1 cm wide flat chisel and a surgical hammer. * The corticocancellous graft was manipulated using a rongeur to reproduce the shape of the peri-implant bone defect. * The graft was carefully inserted to the level of the implant platform Finally, a screw-retained resin provisional crown, relined over a polyetheretherketone (PEEK) anti-rotation abutment, was placed out of occlusion, establishing the ideal emergence profile to accommodate the soft tissues and to promote a thicker and more stable gingival tissue margin |
| Control group Ice cream cone technique | Active comparator | Procedure: Ice cream cone techniqueIce cream cone technique 1. Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. 2. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates. The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using resorbable sutures to prevent dislodgment of the blood clot and bone grafting material |
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.
- 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.
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 Dentoalveolar RestorationTopical 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. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. • Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability | Procedure or surgery | Intervention group Immediate Dentoalveolar Restoration |
| Ice cream cone techniqueTopical 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. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. • Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability | Procedure or surgery | Control group Ice cream cone technique |
Primary outcome
Bucco/facial-palatal ridge thickness
Time frame: 1 year
Impressions were taken with addition silicone before tooth extraction, after six months of implant placement (immediately after the placement of the definite crown) and 12 months after crown installation. Casts were then obtained with special gypsum stone type IV.Casts were measured by a dentist not involved in the study with a digital caliper. Three reference points were measured from the free gingival margin to the apex at the implant site and in the contralateral tooth: 0 mm, 3 mm and 6 mm
11 secondary outcomes
Radiographic bucco-palatal bone changes
Time frame: 1 year
3. Radiographic width of bone labial to the implant
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Dentoalveolar Restoration and Ice cream cone technique in people with Immediate Implant, run by Aya Sharaf 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 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bucco/facial-palatal ridge thickness (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 17 Sep 2026.