Socket ShieldPhase 3NCT03684356
Comparison of Peri-implant Tissues Using Socket Shield Technique Versus Xenograft
A Phase 3 study testing socket shield technique and xenograft in people with Socket Shield, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Shield
- What is being tested?
- socket shield technique and xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2019to Dec 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's age was 18 years or older.
- Non-restorable tooth in the upper inter-bicuspid area.
- Adequate bone volume for the placement of immediate implant.
- Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
- Primary stability of the implant was achieved at the time of the implant placement.
Who cannot join
- Patients who reported tobacco use in the past 5 years.
- Patients who had severe periodontal destruction at the site of implant placement.
- The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
- Patients who had history of any systemic disease that precludes the placement of implants.
- Any disease that might affect bone metabolism as osteoporosis.
- Patients taking medications that might affect bone turn over as bisphosphonates.
Show all 10Show fewer
- Physically or mentally handicapped patients.
- Pregnant females.
- Teeth with vertical root fractures on the buccal aspect
- Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial
The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.
Read the detailed description
to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.
- Population (P): Patients with single non-restorable tooth in the esthetic zone.
- Intervention (I): Immediate implant placement with socket shield technique.
- Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
- Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
- Time frame: 9 months (Chu et al., 2015).
- Study design: Randomized controlled clinical trial.
- Conditions
- Socket Shield
- Being tested
- socket shield technique, xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket shield techniqueProcedure or surgery
immediate implant placement with buccal part of the root is retained
xenograftProcedure or surgery
immediate implant placement with filling the buccal gap with xenograft
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | immediate implant with socket shield technique Receives: Procedure: socket shield technique |
| control | Active comparator | immediate implant placement with filling the buccal gap with xenograft Receives: Procedure: xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
Measured: 9 months
Secondary outcomes (4)
Recession of the buccal peri-implant mucosa
measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.
Measured: 9 months
Corono-apical peri-implant bone dimensional changes
measured at the middle of the buccal implant surface after the superimposition of Cone Beam C.T scans as the difference between the former and new vertical distance from the implant platform to the buccal alveolar crest
Measured: 6 months
Bucco-lingual peri-implant bone dimensional changes
measured at middle of the buccal implant surface 1mm below the alveolar crest after the superimposition of the Cone Beam C.T scans as the difference between the former and new horizontal distance between the buccal and the palatal plate of bone
Measured: 6 months
Patient satisfaction: VAS
Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled "much less than natural teeth" which is marked by zero and the left anchor labeled "much more" which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start22 Feb 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Socket ShieldStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Atef Abd El Moneium, Cairo University
- Investigators
- Amr F Zahran, Professor, Study chair, Professor in Department of Oral Medicine and Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684356
- Sponsor's protocol ID
- CairoU12
- Status last verified
- Feb 2020
- First submitted
- 24 Sep 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
PubMed 28333394Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.
PubMed 29489581Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.
PubMed 29333449Siormpas KD, Mitsias ME, Kontsiotou-Siormpa E, Garber D, Kotsakis GA. Immediate implant placement in the esthetic zone utilizing the "root-membrane" technique: clinical results up to 5 years postloading. Int J Oral Maxillofac Implants. 2014 Nov-Dec;29(6):1397-405. doi: 10.11607/jomi.3707. Epub 2014 Sep 26.
PubMed 25265125Tan Z, Kang J, Liu W, Wang H. The effect of the heights and thicknesses of the remaining root segments on buccal bone resorption in the socket-shield technique: An experimental study in dogs. Clin Implant Dent Relat Res. 2018 Jun;20(3):352-359. doi: 10.1111/cid.12588. Epub 2018 Feb 8.
PubMed 29417708Atef M, El Barbary A, Dahrous MSE, Zahran AF. Comparison of the soft and hard peri-implant tissue dimensional changes around single immediate implants in the esthetic zone with socket shield technique versus using xenograft: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):456-465. doi: 10.1111/cid.13008. Epub 2021 May 24.
PubMed 34028974
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03684356
- Acronym / sponsor ID
- CairoU12
- Conditions
- Socket Shield
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Sep 2018 (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 aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.
Detailed description
to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.
- Population (P): Patients with single non-restorable tooth in the esthetic zone.
- Intervention (I): Immediate implant placement with socket shield technique.
- Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
- Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
- Time frame: 9 months (Chu et al., 2015).
- Study design: Randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: socket shield techniqueimmediate implant with socket shield technique |
| control | Active comparator | Procedure: xenograftimmediate implant placement with filling the buccal gap with xenograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient's age was 18 years or older.
- Non-restorable tooth in the upper inter-bicuspid area.
- Adequate bone volume for the placement of immediate implant.
- Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
- Primary stability of the implant was achieved at the time of the implant placement.
Key exclusion criteria (10 listed)
- Patients who reported tobacco use in the past 5 years.
- Patients who had severe periodontal destruction at the site of implant placement.
- The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
- Patients who had history of any systemic disease that precludes the placement of implants.
- Any disease that might affect bone metabolism as osteoporosis.
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 |
|---|---|---|
| socket shield techniqueimmediate implant placement with buccal part of the root is retained | Procedure or surgery | experimental |
| xenograftimmediate implant placement with filling the buccal gap with xenograft | Procedure or surgery | control |
Primary outcome
pink esthetic score
Time frame: 9 months
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
4 secondary outcomes
Recession of the buccal peri-implant mucosa
Time frame: 9 months
Corono-apical peri-implant bone dimensional changes
Time frame: 6 months
Bucco-lingual peri-implant bone dimensional changes
Time frame: 6 months
Patient satisfaction: VAS
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 28333394Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
- Background: PubMed 29489581Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.
- Background: PubMed 29333449Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.
- Background: PubMed 25265125Siormpas KD, Mitsias ME, Kontsiotou-Siormpa E, Garber D, Kotsakis GA. Immediate implant placement in the esthetic zone utilizing the "root-membrane" technique: clinical results up to 5 years postloading. Int J Oral Maxillofac Implants. 2014 Nov-Dec;29(6):1397-405. doi: 10.11607/jomi.3707. Epub 2014 Sep 26.
- Background: PubMed 29417708Tan Z, Kang J, Liu W, Wang H. The effect of the heights and thicknesses of the remaining root segments on buccal bone resorption in the socket-shield technique: An experimental study in dogs. Clin Implant Dent Relat Res. 2018 Jun;20(3):352-359. doi: 10.1111/cid.12588. Epub 2018 Feb 8.
- Derived from this study: PubMed 34028974Atef M, El Barbary A, Dahrous MSE, Zahran AF. Comparison of the soft and hard peri-implant tissue dimensional changes around single immediate implants in the esthetic zone with socket shield technique versus using xenograft: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):456-465. doi: 10.1111/cid.13008. Epub 2021 May 24.
- Individual participant dataSharing planned: No
Related trials for Socket Shield
Recruiting
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Effect of Subepithelial Connective Tissue Graft With Socket Shield Technique
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Recruiting
Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.
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Not yet recruiting
Socket Shield Technique With CGF and Xenograft for Immediate Implants
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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.
Amr F Zahran, Professor study chair
Professor in Department of Oral Medicine and Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing socket shield technique and xenograft in people with Socket Shield, 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 5 inclusion and 10 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 18 Feb 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 A Abd El Moneium, Ass.lecturer (01224302609 ext. 002, matef1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pink esthetic score (time frame: 9 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 NCT03684356, which also lists 6 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 18 Feb 2020.