Immediate ImplantsNCT06478511
Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants
A study testing Classic Immediate implant, Immediate implant combined with subepithelial connective tissue graft and Immediate dental implant placement using socket shield technique in people with Immediate Implants, run by Mansoura University at 1 site in Egypt.
Trial summary
The purposes of study are: 1. To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically. 2. To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implants
- What is being tested?
- Classic Immediate implant, Immediate implant combined with subepithelial connective tissue graft and Immediate dental implant placement using socket shield technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2020to 20 Apr 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/female patients, age: >18 years.
- Healthy periodontium with gingival biotype at least 2mm.
- Extraction socket with four intact walls.
- Adequate native bone to achieve good primary stability.
- No untreated carious lesions.
- Missing anterior (incisor/canine) with healthy adjacent teeth bilaterally.
- Useless broken single-tooth with only lingual root fracture caused by trauma.
Who cannot join
- History of systemic disease (excluding well-controlled diabetes).
- Recent infectious diseases or surgical treatment within 30 days.
- Smokers (≥10 cigarettes a day).
- Pregnancy or lactation.
- Patients on regular medications affecting periodontal healing (e.g., phenytoin, dihydropyridines, calcium antagonists, and cyclosporine) or anticoagulant therapy with warfarin, clopidogrel, ticlopidine, and aspirin.
- Presence of pathological lesions around the surgical area.
- Severe mental disorders or uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants In Maxillary Esthetic Region: A Randomized Controlled Study
The purposes of study are:
- To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically.
- To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically.
- To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
- To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
Read the detailed description
Patient's selection:
Patients in this study will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Mansoura University.
Patients participating in this study will sign an informed consent demonstrating the purpose of this study, treatment procedure, probable risks and benefits from this treatment procedure. The study proposal will be reviewed by the faculty's Research Ethics Committee.
All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed.
Surgical procedures:
Before surgery, Preoperative antibiotics will be given orally one hour prior to surgery (amoxicillin, 2g, or clindamycin, 600 mg, for patients allergic to penicillin) the patients will be advised to rinse for one minute with chlorhexidiene mouthwash. After local anesthesia administration, In group 1, the teeth will be extracted gently using periotomes, in an attempt to preserve facial and lingual bone plates. The sockets will be debrided of soft tissue and irrigated. Then all walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone. The length and width of extracted roots will be measured to determine the length and diameter of implants placed. The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturer's instructions, with maximum use of bone apical to the extraction sockets. The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement, taking care of the anatomical boundaries. After the osteotomy sites had been prepared, the implants will be placed.
In group 2, concerning the donor site of the connective tissue, connective tissue graft was harvested from palate using trap door technique (27) utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, creating a door, the door is then undermined and opened using a sharp dissection, the underlying connective tissue is then harvested using a periosteal elevator, and the door was then sutured using 4 0 silk sutures Finally, the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures.
In group 3, the crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur coupled to a hydrated high-speed handpiece. Sectioning will divide the tooth root into facial and palatal halves with the intention of preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root will be then carefully delivered with so as not to disturb the facial root section.
The remaining root section will be then reduced coronally to 1 mm above the alveolar crest, and will be thinned slightly to a concave contour by careful application in an apico-coronal and mesiodistal direction with a long shanked round diamond. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe. With the preparation steps complete, the tooth root hereafter will be known as the socket-shield. An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the socket shield with the implant 2 mm below the facial crest.
Immediate temporary dentures were fabricated using plastic and inserted on the day of implantation. Patients were instructed to consume soft food for eight weeks. Following a healing period of 6 months, the final restorations will be delivered.
- Conditions
- Immediate Implants
- Being tested
- Classic Immediate implant, Immediate implant combined with subepithelial connective tissue graft, Immediate dental implant placement using socket shield technique
- Keywords
- Immediate implants,Socket shield technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Immediate implantProcedure or surgery
The teeth will be extracted gently using periotomes to preserve facial and lingual bone plates. All walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone. The length and width of extracted roots will be measured to determine the length and diameter of implants placed. The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturer's instructions, with maximum use of bone apical to the extraction sockets. The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement, taking care of the anatomical boundaries. The implants will be placed.
Immediate implant combined with subepithelial connective tissue graftProcedure or surgery
Connective tissue graft was harvested from palate using trap door technique utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, the door is then undermined and opened using a sharp dissection, the underlying connective tissue is then harvested using a periosteal elevator, and the door was then sutured using 4 0 silk sutures Finally, the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures.
Immediate dental implant placement using socket shield techniqueProcedure or surgery
The crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur. Preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root removed gentelly.The remaining root section will be then reduced coronally to 1 mm above the alveolar crest.The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe. With the preparation steps complete, the tooth root hereafter will be known as the socket-shield. An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the shield with the implant 2 mm below the facial crest.
| Study group | Role | What they receive |
|---|---|---|
| Classic immediate implant | Active comparator | Include 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction. Receives: Procedure: Classic Immediate implant |
| Immediate implant combined with subepithelial connective tissue graft | Active comparator | Include 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed. Receives: Procedure: Immediate implant combined with subepithelial connective tissue graft |
| Immediate implant using socket shield technique | Active comparator | include 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique. Receives: Procedure: Immediate dental implant placement using socket shield technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of socket shield technique in immediate implant placement
Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.
Measured: 6 months
Clinical success of socket shield technique in immediate implant placement
Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.
Measured: 12 months
Clinical success of SECT graft in immediate implant placement
Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.
Measured: 6 months
Clinical success of SECT graft in immediate implant placement
Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.
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 posted27 Jun 2024
- Study start5 Dec 2020
- Primary completion10 Sep 2023
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate ImplantsStudies 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
- Model description
- Patients participating in this study will sign an informed consent demonstrating the purpose of this study, treatment procedure, probable risks and benefits from this treatment procedure. Patients will be randomly allocated to one of three groups: 1. Group 1 (control group): Will include 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction. 2. Group 2 : Will include 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed. 3. Group 3: Will include 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique. All osteotomy sites will receive Biogap® bone graft if there are gap between implant and labial bone/ buccal shield ≥ 2mm. All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed tomography.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohammed, Mansoura University
- Investigators
- Samah H Elmeadawy, PhD, Study chair, Professor Of Periodontology, Faculty Of Dentistry, Mansoura UniversityBassant H Elmowafey, PhD, Study director, Professor Of Oral Radiology Faculty Of Dentistry, Mansoura UniversityHesham Abdallah, MSc, Principal investigator, PhD researcher at Faculty Of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478511
- Sponsor's protocol ID
- SECT / SST immediate implant
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun C, Zhao J, Liu Z, Tan L, Huang Y, Zhao L, Tao H. Comparing conventional flap-less immediate implantation and socket-shield technique for esthetic and clinical outcomes: A randomized clinical study. Clin Oral Implants Res. 2020 Feb;31(2):181-191. doi: 10.1111/clr.13554. Epub 2019 Dec 13.
PubMed 31680339Zhang Z, Dong Y, Yang J, Xu R, Deng F. Effect of socket-shield technique on alveolar ridge soft and hard tissue in dogs. J Clin Periodontol. 2019 Feb;46(2):256-263. doi: 10.1111/jcpe.13073.
PubMed 30661247
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subepithelial Connective Tissue Graft Versus Socket Shield Technique In Immediately Placed Implants In Maxillary Esthetic Region: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06478511
- Acronym / sponsor ID
- SECT / SST immediate implant
- Conditions
- Immediate Implants
- Keywords
- Immediate implants,Socket shield technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 27 Jun 2024 (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.
The purposes of study are:
- To assess the efficacy of immediate implant placement in preserving hard and soft tissue around implants clinically and radiographically.
- To assess the efficacy of immediate implant placement combined with subepithelial connective tissue graft in preserving hard and soft tissue around implants clinically and radiographically.
- To assess the efficacy of implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
- To compare immediate implant placement versus implants installed immediately using Socket Shield Technique in preserving hard and soft tissue around implants clinically and radiographically.
Detailed description
Patient's selection:
Patients in this study will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Mansoura University.
Patients participating in this study will sign an informed consent demonstrating the purpose of this study, treatment procedure, probable risks and benefits from this treatment procedure. The study proposal will be reviewed by the faculty's Research Ethics Committee.
All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed.
Surgical procedures:
Before surgery, Preoperative antibiotics will be given orally one hour prior to surgery (amoxicillin, 2g, or clindamycin, 600 mg, for patients allergic to penicillin) the patients will be advised to rinse for one minute with chlorhexidiene mouthwash. After local anesthesia administration, In group 1, the teeth will be extracted gently using periotomes, in an attempt to preserve facial and lingual bone plates. The sockets will be debrided of soft tissue and irrigated. Then all walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone. The length and width of extracted roots will be measured to determine the length and diameter of implants placed. The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturer's instructions, with maximum use of bone apical to the extraction sockets. The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement, taking care of the anatomical boundaries. After the osteotomy sites had been prepared, the implants will be placed.
In group 2, concerning the donor site of the connective tissue, connective tissue graft was harvested from palate using trap door technique (27) utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, creating a door, the door is then undermined and opened using a sharp dissection, the underlying connective tissue is then harvested using a periosteal elevator, and the door was then sutured using 4 0 silk sutures Finally, the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures.
In group 3, the crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur coupled to a hydrated high-speed handpiece. Sectioning will divide the tooth root into facial and palatal halves with the intention of preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root will be then carefully delivered with so as not to disturb the facial root section.
The remaining root section will be then reduced coronally to 1 mm above the alveolar crest, and will be thinned slightly to a concave contour by careful application in an apico-coronal and mesiodistal direction with a long shanked round diamond. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe. With the preparation steps complete, the tooth root hereafter will be known as the socket-shield. An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the socket shield with the implant 2 mm below the facial crest.
Immediate temporary dentures were fabricated using plastic and inserted on the day of implantation. Patients were instructed to consume soft food for eight weeks. Following a healing period of 6 months, the final restorations will be delivered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients participating in this study will sign an informed consent demonstrating the purpose of this study, treatment procedure, probable risks and benefits from this treatment procedure. Patients will be randomly allocated to one of three groups: 1. Group 1 (control group): Will include 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction. 2. Group 2 : Will include 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed. 3. Group 3: Will include 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique. All osteotomy sites will receive Biogap® bone graft if there are gap between implant and labial bone/ buccal shield ≥ 2mm. All the selected patients will receive full mouth scaling, preoperative periapical x-ray and cone beam computed tomography.
| Arm | Type | Receives |
|---|---|---|
| Classic immediate implant | Active comparator | Procedure: Classic Immediate implantInclude 11 implants (Nucleoss T6®) , maximum two per patient, will be placed immediately after atraumatic extraction. |
| Immediate implant combined with subepithelial connective tissue graft | Active comparator | Procedure: Immediate implant combined with subepithelial connective tissue graftInclude 11 implants, maximum two per patient will be placed immediately after atraumatic extraction and subepithelial connective tissue graft will be harvested and placed. |
| Immediate implant using socket shield technique | Active comparator | Procedure: Immediate dental implant placement using socket shield techniqueinclude 11 implants, maximum two per patient will be placed immediately using Socket Shield Technique. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male/female patients, age: >18 years.
- Healthy periodontium with gingival biotype at least 2mm.
- Extraction socket with four intact walls.
- Adequate native bone to achieve good primary stability.
- No untreated carious lesions.
Key exclusion criteria (7 listed)
- History of systemic disease (excluding well-controlled diabetes).
- Recent infectious diseases or surgical treatment within 30 days.
- Smokers (≥10 cigarettes a day).
- Pregnancy or lactation.
- Patients on regular medications affecting periodontal healing (e.g., phenytoin, dihydropyridines, calcium antagonists, and cyclosporine) or anticoagulant therapy with warfarin, clopidogrel, ticlopidine, and aspirin.
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 |
|---|---|---|
| Classic Immediate implantThe teeth will be extracted gently using periotomes to preserve facial and lingual bone plates. All walls of the socket will be inspected and checked for the presence of fenestration or dehiscence defects in bone. The length and width of extracted roots will be measured to determine the length and diameter of implants placed. The osteotomy sites will be prepared and the drills will be used in proper sequence according to manufacturer's instructions, with maximum use of bone apical to the extraction sockets. The drills will extend 3 to 5 mm beyond the apex of the socket to ensure primary stability after placement, taking care of the anatomical boundaries. The implants will be placed. | Procedure or surgery | Classic immediate implant |
| Immediate implant combined with subepithelial connective tissue graftConnective tissue graft was harvested from palate using trap door technique utilizing a horizontal incision 3-4 mm away from the gingival margin with two vertical incisions on the either end of the first incision, the door is then undermined and opened using a sharp dissection, the underlying connective tissue is then harvested using a periosteal elevator, and the door was then sutured using 4 0 silk sutures Finally, the connective tissue graft was immediately placed into the recipient site after a tunneling procedure and sutured with 6-0 nonresorbable monofilament sutures. | Procedure or surgery | Immediate implant combined with subepithelial connective tissue graft |
| Immediate dental implant placement using socket shield techniqueThe crown of the involved tooth will be removed and the root will be then sectioned in a mesiodistal direction along its long axis as far apical as was possible using a long shank fissure bur. Preserving the facial root section unmanipulated and attached to the tooth socket. Periotomes will be then inserted between the palatal root removed gentelly.The remaining root section will be then reduced coronally to 1 mm above the alveolar crest.The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section will be checked for immobility with a sharp probe. With the preparation steps complete, the tooth root hereafter will be known as the socket-shield. An osteotomy will be then sequentially prepared and internal conical connection implant was inserted palatal to the shield with the implant 2 mm below the facial crest. | Procedure or surgery | Immediate implant using socket shield technique |
Primary outcome
Clinical success of socket shield technique in immediate implant placement
Time frame: 6 months
Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.
Clinical success of socket shield technique in immediate implant placement
Time frame: 12 months
Implant placement using socket shield technique, including: shortened treatment time and minimizes alveolar bone loss.
Clinical success of SECT graft in immediate implant placement
Time frame: 6 months
Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.
Clinical success of SECT graft in immediate implant placement
Time frame: 12 months
Implant placement with SECT graft, including: shortened treatment time and minimizes alveolar bone loss.
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 27 Jun 2024.
- Results publication: PubMed 31680339Sun C, Zhao J, Liu Z, Tan L, Huang Y, Zhao L, Tao H. Comparing conventional flap-less immediate implantation and socket-shield technique for esthetic and clinical outcomes: A randomized clinical study. Clin Oral Implants Res. 2020 Feb;31(2):181-191. doi: 10.1111/clr.13554. Epub 2019 Dec 13.
- Results publication: PubMed 30661247Zhang Z, Dong Y, Yang J, Xu R, Deng F. Effect of socket-shield technique on alveolar ridge soft and hard tissue in dogs. J Clin Periodontol. 2019 Feb;46(2):256-263. doi: 10.1111/jcpe.13073.
- Individual participant dataSharing planned: No
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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.
Samah H Elmeadawy, PhD study chair
Professor Of Periodontology, Faculty Of Dentistry, Mansoura University
Bassant H Elmowafey, PhD study director
Professor Of Oral Radiology Faculty Of Dentistry, Mansoura University
Hesham Abdallah, MSc principal investigator
PhD researcher at Faculty Of Dentistry, Mansoura 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 Classic Immediate implant, Immediate implant combined with subepithelial connective tissue graft and Immediate dental implant placement using socket shield technique in people with Immediate Implants, run by Mansoura 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 7 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 27 Jun 2024. 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?
Clinical success of socket shield technique in immediate implant placement (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06478511, which also lists 2 linked publications.
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 27 Jun 2024.