Immediate ImplantsNCT05673122
Socket-Shield Technique With Immediate Implant
A study testing Implant(Flotecno) in people with Immediate Implants, run by Ain Shams University at 1 site in Egypt.
Trial summary
Primary Objective: Evaluate of labial plate of bone changes using immediate implant with the socket shield technique in anterior esthetic zone. Secondary Objective: Evaluate of soft tissue changes using the immediate implant with socket shield technique in anterior esthetic zone. 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?
- Implant(Flotecno)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Mar 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:.1. Healthy adlult patient 2. Age from 20-50 years old. 3 Tooth involved in the esthetic zone. 4. Socket Type I. (Elian et al., 2007) 5. Natural teeth adjacent to the involved tooth should be free from periapcial infection.
- Sufficient hard and soft tissue volume in vertical and buccolingual direction (Levine et al., 2014) 7. Good oral hygiene. 8. Indication for tooth extraction included :( Degidi et al., 2010)
- Non-restorable teeth
- Remaining roots
- Endodontic failures
Exclusion Criteria :1. Presence of acute dento-alveolar infection of involved tooth.
- Pregnant and breast feeding. 3. Smokers. (Takamiya et al., 2013) 4. Decision impaired individuals (prisoners, handicapped, and mentally retarded) 5. Vertical or Horizontal root fractures on buccal aspect below bone level. 6. External or internal root resorption.
-
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Nasr City, 0020
Mohamed W Bissar, Ass.pro, 00201006687399, Mohamedbissar_1@yahoo.com
Mohamed Sh El-Mofty, Prof.Dr, 00201001431000, Mofty@dr.com
About this study
Official title: Socket-Shield Technique With Immediate Implant Placement for Labial Bone Preservation
Primary Objective:
Evaluate of labial plate of bone changes using immediate implant with the socket shield technique in anterior esthetic zone.
Secondary Objective:
Evaluate of soft tissue changes using the immediate implant with socket shield technique in anterior esthetic zone.
Read the detailed description
Dental implants have become a standard treatment in the replacement of missing teeth. After tooth extraction and implant placement, resorption of buccal bundle bone can pose a significant complication with often very negative cosmetic impacts. Remodeling of the labial bone plate after extraction is a common challenge that affects the final esthetic outcome especially in the esthetic zone.
In addition to, marked bone loss in the horizontal plane and vertical height of the socket wall occurs during the first year after extraction, and one third of this total bone loss occurs during the first three months.
As the buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue.
It was suggested that following tooth extraction, the blood vessels in periodontium to the thin bone walls are severed, thereby causing facial bone plate resorption. Thus, it can be assumed that retaining a root may alter the occurrence of facial bone resorption. Many studies showed that the retention of the decoronated root, vital or endodontically treated as root submerge technique, can preserve the alveolar bone.
Other studies also proved that the placement of the implant in contact with retained root surface preserved the buccal bone and led to good emergence profile, Hürzeler et al. (2010) were the first to demonstrate the socket-shield technique in a study on one beagle dog. Were Modification of original technique was done by many researchers by preserving the palatal bone and proximal bone. The promising result of this study shows socket shield technique as a feasible alternative treatment option for thin buccal plate region area and periodontally healthy teeth.
Flapless technique can decrease the amount of bone resorption. Thus, helping in preservation of the inter-dental papilla. Also, it provides less traumatic surgery, decreased operative time, rapid healing and less postoperative complications.
The socket-shield (SS) technique provides a promising treatment adjunct to better manage these risks and preserve the post-extraction tissues in aesthetically challenging cases. The principle is to prepare the root of a tooth indicated for extraction in such a manner that the buccal / facial root section remains in-situ with its physiologic relation to the buccal plate intact.
The socket shield procedure is a novel technique for post extraction implant placement. Several modifications of partial extraction therapy and simultaneous implant placement have been presented since its inception. In this study we discuss the most contemporary step-by-step surgical technique of the socket shield procedure with detailed illustrations and representative cases.
- Conditions
- Immediate Implants
- Being tested
- Implant(Flotecno)
- Keywords
- extraction socket, immediate implants, socket shield, labial bone thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant(Flotecno)Device
The implants It has a tapered body design and Sandblasting with Large grit that facilitates the osseointergration process.
made in Italy Flotecno srl via.Turati,38 20121 MILANO (Italia)
| Study group | Role | What they receive |
|---|---|---|
| Implant intact with shield | Experimental | Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield. Receives: Device: Implant(Flotecno) |
| Implant not intact with shield | Experimental | Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft. Receives: Device: Implant(Flotecno) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of labial bone thickness
With the help of CBCT ;Horizontal bone level measurement: Three horizontal lines are drawn 2, 4, and 6 mm apical to implant platform to outer surface of buccal plate of bone. Facial plate of bone is taken as a reference point and is measured baseline (after implant placement and at 6 months follow up).
Measured: baseline at day of surgery and after 6 months
Secondary outcomes (1)
Pink esthetic score (PES)
Pink esthetic evaluation criteria:
The Pink Esthetic Score is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.
The mesial and distal papilla were evaluated for completeness, incompleteness or absence. All other variables were assessed by comparison with a reference tooth, i.e., the corresponding tooth (anterior region) or a neighboring tooth (pre-molar region) or evaluate (PES) evaluation before extraction and at six months follow up of involved tooth.
Measured: baseline presurgery and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Twenty patients were randomly assigned by specific computer software into two groups either in group (I) or group (II). Group I: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield. Group II: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asrar Moustafa Muftah Althabet, Ain Shams University
- Investigators
- Ahmed A Hassan, Prof.Dr, Study chair, Ain Shams UniversityAsrar M Althabet, MSC, Principal investigator, Faculty of dentistry Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673122
- Sponsor's protocol ID
- socket shield
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdullah AH, Abdel Gaber HK, Adel-Khattab D. Evaluation of soft tissue and labial plate of bone stability with immediate implant in direct contact versus gap with socket shield: A randomized clinical trial with 1 year follow-up. Clin Implant Dent Relat Res. 2022 Oct;24(5):548-558. doi: 10.1111/cid.13117. Epub 2022 Jun 28.
PubMed 35763398Degidi M, Daprile G, Piattelli A. Determination of primary stability: a comparison of the surgeon's perception and objective measurements. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):558-61.
PubMed 20556255Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Salama M, Ishikawa T, Salama H, Funato A, Garber D. Advantages of the root submergence technique for pontic site development in esthetic implant therapy. Int J Periodontics Restorative Dent. 2007 Dec;27(6):521-7.
PubMed 18092446Gluckman H, Nagy K, Du Toit J. Prosthetic management of implants placed with the socket-shield technique. J Prosthet Dent. 2019 Apr;121(4):581-585. doi: 10.1016/j.prosdent.2018.06.009. Epub 2018 Dec 13.
PubMed 30554825Mourya A, Mishra SK, Gaddale R, Chowdhary R. Socket-shield technique for implant placement to stabilize the facial gingival and osseous architecture: A systematic review. J Investig Clin Dent. 2019 Nov;10(4):e12449. doi: 10.1111/jicd.12449. Epub 2019 Aug 21.
PubMed 31433130Lin X, Gao Y, Ding X, Zheng X. Socket shield technique: A systemic review and meta-analysis. J Prosthodont Res. 2022 Apr 27;66(2):226-235. doi: 10.2186/jpr.JPR_D_20_00262. Epub 2021 Sep 16.
PubMed 34526435Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.
PubMed 22211305Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.
PubMed 20712701Vittorini Orgeas G, Clementini M, De Risi V, de Sanctis M. Surgical techniques for alveolar socket preservation: a systematic review. Int J Oral Maxillofac Implants. 2013 Jul-Aug;28(4):1049-61. doi: 10.11607/jomi.2670.
PubMed 23869363
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket-Shield Technique With Immediate Implant Placement for Labial Bone Preservation
- ClinicalTrials.gov ID
- NCT05673122
- Acronym / sponsor ID
- socket shield
- Conditions
- Immediate Implants
- Keywords
- extraction socket, immediate implants, socket shield, labial bone thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 6 Jan 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.
Primary Objective:
Evaluate of labial plate of bone changes using immediate implant with the socket shield technique in anterior esthetic zone.
Secondary Objective:
Evaluate of soft tissue changes using the immediate implant with socket shield technique in anterior esthetic zone.
Detailed description
Dental implants have become a standard treatment in the replacement of missing teeth. After tooth extraction and implant placement, resorption of buccal bundle bone can pose a significant complication with often very negative cosmetic impacts. Remodeling of the labial bone plate after extraction is a common challenge that affects the final esthetic outcome especially in the esthetic zone.
In addition to, marked bone loss in the horizontal plane and vertical height of the socket wall occurs during the first year after extraction, and one third of this total bone loss occurs during the first three months.
As the buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue.
It was suggested that following tooth extraction, the blood vessels in periodontium to the thin bone walls are severed, thereby causing facial bone plate resorption. Thus, it can be assumed that retaining a root may alter the occurrence of facial bone resorption. Many studies showed that the retention of the decoronated root, vital or endodontically treated as root submerge technique, can preserve the alveolar bone.
Other studies also proved that the placement of the implant in contact with retained root surface preserved the buccal bone and led to good emergence profile, Hürzeler et al. (2010) were the first to demonstrate the socket-shield technique in a study on one beagle dog. Were Modification of original technique was done by many researchers by preserving the palatal bone and proximal bone. The promising result of this study shows socket shield technique as a feasible alternative treatment option for thin buccal plate region area and periodontally healthy teeth.
Flapless technique can decrease the amount of bone resorption. Thus, helping in preservation of the inter-dental papilla. Also, it provides less traumatic surgery, decreased operative time, rapid healing and less postoperative complications.
The socket-shield (SS) technique provides a promising treatment adjunct to better manage these risks and preserve the post-extraction tissues in aesthetically challenging cases. The principle is to prepare the root of a tooth indicated for extraction in such a manner that the buccal / facial root section remains in-situ with its physiologic relation to the buccal plate intact.
The socket shield procedure is a novel technique for post extraction implant placement. Several modifications of partial extraction therapy and simultaneous implant placement have been presented since its inception. In this study we discuss the most contemporary step-by-step surgical technique of the socket shield procedure with detailed illustrations and representative cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Twenty patients were randomly assigned by specific computer software into two groups either in group (I) or group (II). Group I: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield. Group II: Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft.
| Arm | Type | Receives |
|---|---|---|
| Implant intact with shield | Experimental | Device: Implant(Flotecno)Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield. |
| Implant not intact with shield | Experimental | Device: Implant(Flotecno)Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Implant(Flotecno)The implants It has a tapered body design and Sandblasting with Large grit that facilitates the osseointergration process. made in Italy Flotecno srl via.Turati,38 20121 MILANO (Italia) | Device | Implant intact with shield, Implant not intact with shield |
Primary outcome
change of labial bone thickness
Time frame: baseline at day of surgery and after 6 months
With the help of CBCT ;Horizontal bone level measurement: Three horizontal lines are drawn 2, 4, and 6 mm apical to implant platform to outer surface of buccal plate of bone. Facial plate of bone is taken as a reference point and is measured baseline (after implant placement and at 6 months follow up).
1 secondary outcome
Pink esthetic score (PES)
Time frame: baseline presurgery and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 35763398Abdullah AH, Abdel Gaber HK, Adel-Khattab D. Evaluation of soft tissue and labial plate of bone stability with immediate implant in direct contact versus gap with socket shield: A randomized clinical trial with 1 year follow-up. Clin Implant Dent Relat Res. 2022 Oct;24(5):548-558. doi: 10.1111/cid.13117. Epub 2022 Jun 28.
- Background: PubMed 20556255Degidi M, Daprile G, Piattelli A. Determination of primary stability: a comparison of the surgeon's perception and objective measurements. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):558-61.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Background: PubMed 18092446Salama M, Ishikawa T, Salama H, Funato A, Garber D. Advantages of the root submergence technique for pontic site development in esthetic implant therapy. Int J Periodontics Restorative Dent. 2007 Dec;27(6):521-7.
- Background: PubMed 30554825Gluckman H, Nagy K, Du Toit J. Prosthetic management of implants placed with the socket-shield technique. J Prosthet Dent. 2019 Apr;121(4):581-585. doi: 10.1016/j.prosdent.2018.06.009. Epub 2018 Dec 13.
- Background: PubMed 31433130Mourya A, Mishra SK, Gaddale R, Chowdhary R. Socket-shield technique for implant placement to stabilize the facial gingival and osseous architecture: A systematic review. J Investig Clin Dent. 2019 Nov;10(4):e12449. doi: 10.1111/jicd.12449. Epub 2019 Aug 21.
- Background: PubMed 34526435Lin X, Gao Y, Ding X, Zheng X. Socket shield technique: A systemic review and meta-analysis. J Prosthodont Res. 2022 Apr 27;66(2):226-235. doi: 10.2186/jpr.JPR_D_20_00262. Epub 2021 Sep 16.
- Background: PubMed 22211305Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.
- Background: PubMed 20712701Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.
- Background: PubMed 23869363Vittorini Orgeas G, Clementini M, De Risi V, de Sanctis M. Surgical techniques for alveolar socket preservation: a systematic review. Int J Oral Maxillofac Implants. 2013 Jul-Aug;28(4):1049-61. doi: 10.11607/jomi.2670.
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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.
Ahmed A Hassan, Prof.Dr study chair
Ain Shams University
Asrar M Althabet, MSC principal investigator
Faculty of dentistry Ain Shams 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 Implant(Flotecno) in people with Immediate Implants, run by Ain Shams 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?
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 6 Jan 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?
Contact Mohamed W Bissar, Ass.Prof (00201006687399, Mohamedbissar_1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of labial bone thickness (time frame: baseline at day of surgery and after 6 months). 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 NCT05673122, which also lists 10 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 6 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.