Socket PerservationPhase 4NCT06695208
Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth
A Phase 4 study testing Biodentine in people with Socket Perservation, run by Cairo University at 1 site in Egypt.
Trial summary
socket preservation using biodentin versus xeno graft for single rooted mandibular teeth Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Socket Perservation
- What is being tested?
- Biodentine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sex with badly decayed tooth indicated for extraction
- The ages of the patients ranged from 25 to 50 years.
- Patients with healthy systemic condition (Medically free)
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene
- Cooperative patients who are willing to commit for 6 months follow up
Who cannot join
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Smokers
- Patient with medical condition that contraindicates surgical procedures
- Pregnant or nursing.
- Substance abuse.
Show all 9Show fewer
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits severe bruxism or clenching.
- Active infection or severe inflammation in the area intended for implant placement.
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Giza
maxin gerges, MSc, +201011466614, maxim.gerges@dentistry.cu.edu.eg
About this study
Official title: Histomorphometric and Radiographic Assessment of Bone After Socket Preservation Using Biodentin Versus Xeno Graft for Socket Preservation of Single Rooted Mandibular Teeth: Randomized Clinical Trial
socket preservation using biodentin versus xeno graft for single rooted mandibular teeth
Read the detailed description
after extraction of single rooted mandibular teeth the socket will be filled with xeno graft or biodentine and the socket will be closed using gel foam and sutures then CBCT will be taken to measure bone width after 6 months of healing CBCT will be taken again to measure the difference in bone width and a core biopsy will be taken followed by implant placement
- Conditions
- Socket Perservation
- Being tested
- Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
biodentine used in socket preservation
| Study group | Role | What they receive |
|---|---|---|
| biodentine group | Experimental | Not described Receives: Drug: Biodentine |
| xeno graft group | Active comparator | Not described Receives: Drug: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography
calculation of bone width gain in millimeters in extraction socket in mandibular single rooted teeth using cone beam computed tomography.
Measured: 6 months postoperative
Secondary outcomes (1)
Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur
assessment of bone quality from extraction socket that were preserved bone will be harvested using trephine bur followed by implant placement
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Socket PerservationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxim Salib Todry Gerges, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695208
- Sponsor's protocol ID
- CEBD_CU_2024-01-26
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Starch-Jensen T, Vitenson J, Deluiz D, Ostergaard KB, Tinoco EMB. Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2022 Mar 31;13(1):e1. doi: 10.5037/jomr.2022.13101. eCollection 2022 Jan-Mar.
PubMed 35574210Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
PubMed 21050499Henry PJ. Tooth loss and implant replacement. Aust Dent J. 2000 Sep;45(3):150-72. doi: 10.1111/j.1834-7819.2000.tb00552.x.
PubMed 11062933Iorio-Siciliano V, Blasi A, Nicolo M, Iorio-Siciliano A, Riccitiello F, Ramaglia L. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e290-e296. doi: 10.11607/prd.2474.
PubMed 28817143Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
PubMed 9776033Rajasekharan S, Martens LC, Cauwels RGEC, Anthonappa RP. Biodentine material characteristics and clinical applications: a 3 year literature review and update. Eur Arch Paediatr Dent. 2018 Feb;19(1):1-22. doi: 10.1007/s40368-018-0328-x. Epub 2018 Jan 25.
PubMed 29372451Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histomorphometric and Radiographic Assessment of Bone After Socket Preservation Using Biodentin Versus Xeno Graft for Socket Preservation of Single Rooted Mandibular Teeth: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06695208
- Acronym / sponsor ID
- CEBD_CU_2024-01-26
- Conditions
- Socket Perservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Nov 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.
socket preservation using biodentin versus xeno graft for single rooted mandibular teeth
Detailed description
after extraction of single rooted mandibular teeth the socket will be filled with xeno graft or biodentine and the socket will be closed using gel foam and sutures then CBCT will be taken to measure bone width after 6 months of healing CBCT will be taken again to measure the difference in bone width and a core biopsy will be taken followed by implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biodentine group | Experimental | Drug: Biodentine |
| xeno graft group | Active comparator | Drug: Biodentine |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of both sex with badly decayed tooth indicated for extraction
- The ages of the patients ranged from 25 to 50 years.
- Patients with healthy systemic condition (Medically free)
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene
Key exclusion criteria (9 listed)
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Smokers
- Patient with medical condition that contraindicates surgical procedures
- Pregnant or nursing.
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 |
|---|---|---|
| Biodentinebiodentine used in socket preservation | Drug | biodentine group, xeno graft group |
Primary outcome
radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography
Time frame: 6 months postoperative
calculation of bone width gain in millimeters in extraction socket in mandibular single rooted teeth using cone beam computed tomography.
1 secondary outcome
Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur
Time frame: 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Results publication: PubMed 35574210Starch-Jensen T, Vitenson J, Deluiz D, Ostergaard KB, Tinoco EMB. Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2022 Mar 31;13(1):e1. doi: 10.5037/jomr.2022.13101. eCollection 2022 Jan-Mar.
- Results publication: PubMed 21050499Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
- Results publication: PubMed 11062933Henry PJ. Tooth loss and implant replacement. Aust Dent J. 2000 Sep;45(3):150-72. doi: 10.1111/j.1834-7819.2000.tb00552.x.
- Results publication: PubMed 28817143Iorio-Siciliano V, Blasi A, Nicolo M, Iorio-Siciliano A, Riccitiello F, Ramaglia L. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e290-e296. doi: 10.11607/prd.2474.
- Results publication: PubMed 9776033Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
- Results publication: PubMed 29372451Rajasekharan S, Martens LC, Cauwels RGEC, Anthonappa RP. Biodentine material characteristics and clinical applications: a 3 year literature review and update. Eur Arch Paediatr Dent. 2018 Feb;19(1):1-22. doi: 10.1007/s40368-018-0328-x. Epub 2018 Jan 25.
- Results publication: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft: a Systematic ReviewLink provided by the sponsor.
- Tooth loss and oral health-related quality of life: a systematic review and meta-analysisLink provided by the sponsor.
- Tooth loss and implant replacementLink provided by the sponsor.
- Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical TrialLink provided by the sponsor.
- Preservation of alveolar bone in extraction sockets using bioabsorbable membranesLink provided by the sponsor.
- Biodentine™ material characteristics and clinical applications: a 3 year literature review and updateLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Socket Perservation
Not yet recruitingPhase 3
Clinical Comparison of Xenograft With Hydrogel Versus Xenograft Alone in the Socket Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial
Socket Perservation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biodentine in people with Socket Perservation, 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact maxim gerges, MSc (+201011466614, maxim.gerges@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography (time frame: 6 months postoperative). 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 NCT06695208, which also lists 7 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 19 Nov 2024.