Immediate Dental ImplantsNCT05776498
Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft
A study testing immediate implant placement with particulate bone graft using the dual zone technique. and immediate implant placement with connective tissue grafting in people with Immediate Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implants
- What is being tested?
- immediate implant placement with particulate bone graft using the dual zone technique. and immediate implant placement with connective tissue grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient-related criteria:
- Adults at or above the age of 18.
- Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- Able to tolerate surgical periodontal procedures.
Show all 14Show fewer
- Full mouth plaque and bleeding scores less than 20%.
- Compliance with the maintenance program.
- Provide informed consent.
- Accepts the one-year follow-up period.
- Teeth related criteria:
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
- Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm.
Who cannot join
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft: A Randomized Clinical Trial
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019). In patients with non-restorable teeth in the esthetic zone, will the use of bone grafts to the dual zone with customized healing abutment vs the use of connective tissue graft with customized healing abutment in immediately placed implants shows better buccal contour avoiding horizontal collapse?
- Conditions
- Immediate Dental Implants
- Being tested
- immediate implant placement with particulate bone graft using the dual zone technique., immediate implant placement with connective tissue grafting
- Keywords
- Immediate dental implants, anterior maxilla, esthetic zone, connective tissue graft, dual zone technique, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with particulate bone graft using the dual zone technique.Procedure or surgery
Tooth extraction and immediate implant placement as mentioned, then particulate bone graft will be packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), then will be covered by a customized healing abutment.
immediate implant placement with connective tissue graftingProcedure or surgery
Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with particulate bone graft using the dual zone technique. | Experimental | immediate implant placement with particulate bone graft using the dual zone technique. Receives: Procedure: immediate implant placement with particulate bone graft using the dual zone technique. |
| immediate implant placement with connective tissue grafting | Experimental | immediate implant placement with connective tissue grafting Receives: Procedure: immediate implant placement with connective tissue grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score (PES)
To evaluate the pink esthetic score 1-14 score
Measured: 3 months after crown placement
Secondary outcomes (6)
Volumetric analysis of buccal contour
3D viewer soft tissue; mm changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin
Measured: 6 months
Mid-facial recession
3D viewer soft tissue
Measured: 1 year
Interdental papilla
3D viewer soft tissue
Measured: 1 year
Horizontal labio-palatal bone width
CBCT cone beam CT
Measured: 1 year
Bone formed labial to the implant
CBCT cone beam CT
Measured: 1 year
gingival biotype
thickness in millimeters mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jun 2021
- Primary completion15 May 2023
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental ImplantsStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
- Investigators
- Noha A Ghallab, PhD, Study director, Professor of Oral Medicine & Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776498
- Sponsor's protocol ID
- IDCE.N3
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Immediate Implant Placement Using Dual Zone Approach Versus Connective Tissue Graft: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05776498
- Acronym / sponsor ID
- IDCE.N3
- Conditions
- Immediate Dental Implants
- Keywords
- Immediate dental implants, anterior maxilla, esthetic zone, connective tissue graft, dual zone technique, bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 20 Mar 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.
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019). In patients with non-restorable teeth in the esthetic zone, will the use of bone grafts to the dual zone with customized healing abutment vs the use of connective tissue graft with customized healing abutment in immediately placed implants shows better buccal contour avoiding horizontal collapse?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with particulate bone graft using the dual zone technique. | Experimental | Procedure: immediate implant placement with particulate bone graft using the dual zone technique.immediate implant placement with particulate bone graft using the dual zone technique. |
| immediate implant placement with connective tissue grafting | Experimental | Procedure: immediate implant placement with connective tissue graftingimmediate implant placement with connective tissue grafting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults at or above the age of 18.
- Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- Able to tolerate surgical periodontal procedures.
Key exclusion criteria (6 listed)
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft placement.
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 placement with particulate bone graft using the dual zone technique.Tooth extraction and immediate implant placement as mentioned, then particulate bone graft will be packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), then will be covered by a customized healing abutment. | Procedure or surgery | immediate implant placement with particulate bone graft using the dual zone technique. |
| immediate implant placement with connective tissue graftingTooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. | Procedure or surgery | immediate implant placement with connective tissue grafting |
Primary outcome
pink esthetic score (PES)
Time frame: 3 months after crown placement
To evaluate the pink esthetic score 1-14 score
6 secondary outcomes
Volumetric analysis of buccal contour
Time frame: 6 months
Mid-facial recession
Time frame: 1 year
Interdental papilla
Time frame: 1 year
Horizontal labio-palatal bone width
Time frame: 1 year
Bone formed labial to the implant
Time frame: 1 year
gingival biotype
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Noha A Ghallab, PhD study director
Professor of Oral Medicine & Periodontology
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 implant placement with particulate bone graft using the dual zone technique. and immediate implant placement with connective tissue grafting in people with Immediate Dental Implants, 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 14 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 22 Jun 2023. 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?
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?
pink esthetic score (PES) (time frame: 3 months after crown placement). 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 22 Jun 2023.