Extraction Tooth SocketNCT05047887
Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material
A study testing Modified socket shield technique with autogenous dentin graft material (in one side) and Modified socket shield technique with alloplast graft material (in contralateral side) in people with Extraction Tooth Socket, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Extraction Tooth Socket
- What is being tested?
- Modified socket shield technique with autogenous dentin graft material (in one side) and Modified socket shield technique with alloplast graft material (in contralateral side)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2020to 1 Sep 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
- Intact labial periodontal tissues.
- Ability to read and sign an informed consent form.
Who cannot join
- A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
- Untreated periodontal disease.
- Vertical root fractures on the labial aspect.
- Tooth /teeth with horizontal fractures below bone level.
- Tooth /teeth with external or internal resorptions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological Study)
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.
this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.
- Conditions
- Extraction Tooth Socket
- Being tested
- Modified socket shield technique with autogenous dentin graft material (in one side), Modified socket shield technique with alloplast graft material (in contralateral side)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified socket shield technique with autogenous dentin graft material (in one side)Procedure or surgery
The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix.
Modified socket shield technique with alloplast graft material (in contralateral side)Procedure or surgery
The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used
| Study group | Role | What they receive |
|---|---|---|
| Study group (in one side) | Experimental | Modified socket shield technique with autogenous dentin graft Receives: Procedure: Modified socket shield technique with autogenous dentin graft material (in one side) |
| Control group (in contrlateral side) | Active comparator | Modified socket shield technique with alloplast Receives: Procedure: Modified socket shield technique with alloplast graft material (in contralateral side) |
What is being measured
The primary outcome is the main question the study is designed to answer.
post opertaive edema
This will be assessed in the 1st week postoperatively and measured as follows: None (no inflammation) Mild (intraoral swelling confined to the surgical field) Moderate (extraoral swelling in the surgical zone) Severe (extraoral swelling spreading beyond the surgical zone).
Measured: after 7 days
change in pain score
it will be assessed using VAS It rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain
Measured: 1 week and 3 months
Change in bone density
it will be assessed using CBCT
Measured: at baseline and 3 months
Change in bone height
it will be assessed using CBCT
Measured: at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start28 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction Tooth SocketStudies 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
- Single group
- Model description
- A single group in a split-mouth design, right and left sides are randomly allocated to the intervention group (16 sides in 8 patients)
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047887
- Sponsor's protocol ID
- socket preservation_2020
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material (Clinical and Histological Study)
- ClinicalTrials.gov ID
- NCT05047887
- Acronym / sponsor ID
- socket preservation_2020
- Conditions
- Extraction Tooth Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Sep 2021 (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.
Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.
this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single group in a split-mouth design, right and left sides are randomly allocated to the intervention group (16 sides in 8 patients)
| Arm | Type | Receives |
|---|---|---|
| Study group (in one side) | Experimental | Procedure: Modified socket shield technique with autogenous dentin graft material (in one side)Modified socket shield technique with autogenous dentin graft |
| Control group (in contrlateral side) | Active comparator | Procedure: Modified socket shield technique with alloplast graft material (in contralateral side)Modified socket shield technique with alloplast |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
- Intact labial periodontal tissues.
- Ability to read and sign an informed consent form.
Key exclusion criteria (5 listed)
- A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
- Untreated periodontal disease.
- Vertical root fractures on the labial aspect.
- Tooth /teeth with horizontal fractures below bone level.
- Tooth /teeth with external or internal resorptions.
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 |
|---|---|---|
| Modified socket shield technique with autogenous dentin graft material (in one side)The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix. | Procedure or surgery | Study group (in one side) |
| Modified socket shield technique with alloplast graft material (in contralateral side)The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used | Procedure or surgery | Control group (in contrlateral side) |
Primary outcome
post opertaive edema
Time frame: after 7 days
This will be assessed in the 1st week postoperatively and measured as follows: None (no inflammation) Mild (intraoral swelling confined to the surgical field) Moderate (extraoral swelling in the surgical zone) Severe (extraoral swelling spreading beyond the surgical zone).
change in pain score
Time frame: 1 week and 3 months
it will be assessed using VAS It rates pain on a scale from 1-10, with 0 representing "no pain" and 10 "very much pain
Change in bone density
Time frame: at baseline and 3 months
it will be assessed using CBCT
Change in bone height
Time frame: at baseline and 3 months
it will be assessed using CBCT
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 23 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified socket shield technique with autogenous dentin graft material (in one side) and Modified socket shield technique with alloplast graft material (in contralateral side) in people with Extraction Tooth Socket, run by Hams Hamed Abdelrahman 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 3 inclusion and 5 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 23 Dec 2022. 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?
post opertaive edema (time frame: after 7 days). 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?
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 23 Dec 2022.