Immediate Implant PlacementNCT05990283
Socket Shield Technique and Guided Bone Regeneration
A study testing Socket shield technique and Guided bone regeneration in people with Immediate Implant Placement, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- Socket shield technique and Guided bone regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 20 Jan 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
- Patients with the health status of American Society of Anesthesiologists class I or II,
- Nonsmokers,
- Unrestorable single-rooted tooth in the maxillary esthetic region,
- Periodontally healthy, non-mobile teeth,
- Single implant placement,
- Minimum 3-5 mm available vertical bone apical to the apex,
- Intact socket wall after extraction.
Who cannot join
- Medically compromised patients, especially uncontrolled diabetes,
- Psychiatric problems,
- Pregnancy, lactation, or suspicion of pregnancy,
- A history of radiation therapy to the head and neck region or immunosuppressive therapy,
- Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
- Poor plaque control,
Show all 10Show fewer
- Vertical root fracture on the buccal surface or a horizontal fracture below the bone level,
- External or internal resorption affecting the buccal part of the root,
- Acute infection in the area intended for implant placement,
- Refusal to attend follow-up appointments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement
Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.
Read the detailed description
This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.
- Conditions
- Immediate Implant Placement
- Being tested
- Socket shield technique, Guided bone regeneration
- Keywords
- bone regeneration, dental implant, esthetics, grafts, socket shield technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket shield techniqueProcedure or surgery
For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.
Guided bone regenerationProcedure or surgery
For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.
| Study group | Role | What they receive |
|---|---|---|
| Socket shield technique with immediate implant placement | Experimental | For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Receives: Procedure: Socket shield technique |
| Guided bone regeneration with immediate implant placement | Experimental | For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins. Receives: Procedure: Guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant probing depth
Probing depth measured by Williams periodontal probe
Measured: Four months after implant restoration and first-year follow-up
Modified plaque index
An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Measured: Four months after implant restoration and first-year follow-up
Modified bleeding index
An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Measured: Four months after implant restoration and first-year follow-up
Keratinized mucosa width
The distance from the peri-implant mucosa margin to the mucogingival junction
Measured: Four months after implant restoration and first-year follow-up
Mucosal thickness
The thickness measured at 1.5 mm from the margin by the endodontic spreader
Measured: Four months after implant restoration and first-year follow-up
Radiographic bone level in the horizontal dimension
Horizontal bone level measured at cone beam computed tomography images
Measured: Before implant surgery and first year follow-up
Radiographic bone level in the vertical dimension
Vertical bone level measured at cone beam computed tomography images
Measured: Before implant surgery and first year follow-up
Pink esthetic score
A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result
Measured: Before implant surgery and first year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Nov 2019
- Primary completion27 Dec 2021
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
- Investigators
- Ezgi Ceylan, PhD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990283
- Sponsor's protocol ID
- 0044
- Status last verified
- Nov 2019
- First submitted
- 29 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement
- ClinicalTrials.gov ID
- NCT05990283
- Acronym / sponsor ID
- 0044
- Conditions
- Immediate Implant Placement
- Keywords
- bone regeneration, dental implant, esthetics, grafts, socket shield technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 14 Aug 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.
Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.
Detailed description
This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Socket shield technique with immediate implant placement | Experimental | Procedure: Socket shield techniqueFor the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. |
| Guided bone regeneration with immediate implant placement | Experimental | Procedure: Guided bone regenerationFor the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with the health status of American Society of Anesthesiologists class I or II,
- Nonsmokers,
- Unrestorable single-rooted tooth in the maxillary esthetic region,
- Periodontally healthy, non-mobile teeth,
- Single implant placement,
Key exclusion criteria (10 listed)
- Medically compromised patients, especially uncontrolled diabetes,
- Psychiatric problems,
- Pregnancy, lactation, or suspicion of pregnancy,
- A history of radiation therapy to the head and neck region or immunosuppressive therapy,
- Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
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 techniqueFor the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge. | Procedure or surgery | Socket shield technique with immediate implant placement |
| Guided bone regenerationFor the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins. | Procedure or surgery | Guided bone regeneration with immediate implant placement |
Primary outcome
Peri-implant probing depth
Time frame: Four months after implant restoration and first-year follow-up
Probing depth measured by Williams periodontal probe
Modified plaque index
Time frame: Four months after implant restoration and first-year follow-up
An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Modified bleeding index
Time frame: Four months after implant restoration and first-year follow-up
An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
Keratinized mucosa width
Time frame: Four months after implant restoration and first-year follow-up
The distance from the peri-implant mucosa margin to the mucogingival junction
Mucosal thickness
Time frame: Four months after implant restoration and first-year follow-up
The thickness measured at 1.5 mm from the margin by the endodontic spreader
Radiographic bone level in the horizontal dimension
Time frame: Before implant surgery and first year follow-up
Horizontal bone level measured at cone beam computed tomography images
Radiographic bone level in the vertical dimension
Time frame: Before implant surgery and first year follow-up
Vertical bone level measured at cone beam computed tomography images
Pink esthetic score
Time frame: Before implant surgery and first year follow-up
A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result
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 18 Aug 2023.
- 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.
Ezgi Ceylan, PhD principal investigator
Kutahya Health Sciences 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 Socket shield technique and Guided bone regeneration in people with Immediate Implant Placement, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 18 Aug 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 Turkey (Türkiye). 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?
Peri-implant probing depth (time frame: Four months after implant restoration and first-year follow-up). The study lists 8 primary outcomes in all. 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 18 Aug 2023.