Socket PreservationNCT07344025
Comparative Analysis of 2 Bone Graft Materials in Socket Preservation
A study testing Socket Preservation with Graft Material Allograft in people with Socket Preservation and Alveolar Ridge Augmentation, run by Pharos University in Alexandria at 1 site in Egypt.
Trial summary
Socket preservation procedures after tooth extraction have been designed and implemented to maintain the volume of the bone and gingival tissues, which can decrease following the extraction of the teeth. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation, Alveolar Ridge Augmentation, Dental Implants
- What is being tested?
- Socket Preservation with Graft Material Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Apr 2026
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Systemically healthy individuals
- Non-smokers
- Age between 21 and 50 years
- Indicated for tooth extraction and socket preservation
- Good oral hygiene (full-mouth plaque score <20%)
- Willingness to participate and provide informed consent
Who cannot join
- • Stage III or IV periodontitis
- Active periodontal or periapical infection
- Severely resorbed sockets (buccal bone height <5 mm)
- Smoking more than 10 cigarettes per day
- Pregnancy
- Systemic conditions or medications affecting bone metabolism
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
College of Dentistry, Pharos University
Alexandria
Haitham Sakr, PhD, 3877700, haitham.sakr@pua.edu.eg
About this study
Official title: Comparative Analysis of Healing Outcomes Between Two Bone Graft Materials in Socket Preservation Procedure
Socket preservation procedures after tooth extraction have been designed and implemented to maintain the volume of the bone and gingival tissues, which can decrease following the extraction of the teeth. In this clinical trial we will compare clinically and histologically the effectiveness of two distinct bovine bone graft materials; an allograft and a xenograft, in alveolar ridge preservation procedures following tooth extraction .
Read the detailed description
Patients who seek socket preservation procedures will be identified and recruited from the out clinic of College of Dentistry. Inclusion criteria will be: systemically healthy, non-smoking patients aged 21-50 years, with no bone metabolism affecting medications, good oral hygiene (full-mouth plaque score <20%), and willingness to participate. Exclusion criteria included stage III/IV periodontitis, active periodontal lesions, acute infection, severely resorbed sockets (buccal bone height <5 mm), smoking >10 cigarettes/day, and pregnancy.
Indications for extraction include caries, failed endodontic treatment, unrestorable teeth, and tooth fracture. All patients underwent full periodontal examination and initial therapy (oral hygiene instructions, scaling, and root planing) at least 4 weeks before surgery. Preoperative CBCT scans will be analyzed for baseline conditions. Reference stents will be fabricated and used to standardize bone dimensional measurements.
Sample size estimation was based on detecting a mean dimensional change in ridge width following 2-3 months of healing. With SD = 10%, α = 0.05, and power = 80%, a minimum of 9 sockets per group (18 total) was deemed adequate.
Surgical Protocol All surgical procedures will be performed under local anesthesia (2% lidocaine with 1:100,000 epinephrine). A sulcular incision will be made with a 15c blade, and atraumatic extraction will be achieved using periotomes, tooth separation, and forceps while preserving the buccal plate. Following thorough socket debridement, the buccolingual ridge width will be measured using a periodontal probe and customized stent.
Patients will be randomly allocated into one of two treatment groups:
Group 1: Allograft group (n=9) Group 2: Xenograft group (n=9) In all cases, graft material will be condensed gently from the apical region. Sockets will be covered with a collagen membrane and closed with 4-0 PTFE sutures.
All patients will receive standard postoperative care including: amoxicillin 500 mg TID for 7 days, ibuprofen 600 mg BID, and 0.12% chlorhexidine rinse BID for 7 days (starting 48h post-op). Sutures will be removed after 14 days. Patients will be recalled at 2-3 months for CBCT scans with an identical machine and settings. Buccolingual ridge width and buccal bone thickness will be assessed by superimposing baseline and follow-up scans.
At 3 months, crestal/intrasulcular incisions will be made and flaps elevated for re-entry. Biopsies will be obtained using a 2.0-mm trephine bur (8 mm length) from all grafted sites. A total of 27 biopsies (9 per group) will be collected, coded, and fixed in 10% neutral buffered formalin. Osteotomies will be completed, and implants will be placed per manufacturer protocol.
- Being tested
- Socket Preservation with Graft Material Allograft
- Keywords
- Alveolar ridge preservation, Allograft, Bovine xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Preservation with Graft Material AllograftProcedure or surgery
Also called Socket Preservation with Graft Material Xenograft
Socket preservation will be performed after tooth extraction using graft material Allograft or Xenograft according to standard surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Allograft Group | Experimental | Extraction sockets grafted with cortico-cancellous particulate allograft and covered with a collagen membrane. Receives: Procedure: Socket Preservation with Graft Material Allograft |
| Xenograft Group | Experimental | Extraction sockets grafted with xenograft material and covered with a collagen membrane. Receives: Procedure: Socket Preservation with Graft Material Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in buccolingual ridge width
Difference in ridge width measured clinically and radiographically between baseline and 2-3 months post-extraction
Measured: Baseline to 2-3 months
Secondary outcomes (1)
Histomorphometric outcomes
Percentage of new bone formation, residual graft material, and soft tissue/marrow space
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Sakr, Pharos University in Alexandria
- Investigators
- H Sakr, PhD, Principal investigator, Pharos university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344025
- Sponsor's protocol ID
- PharosU
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Healing Outcomes Between Two Bone Graft Materials in Socket Preservation Procedure
- ClinicalTrials.gov ID
- NCT07344025
- Acronym / sponsor ID
- PharosU
- Keywords
- Alveolar ridge preservation, Allograft, Bovine xenograft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Jan 2026 (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 procedures after tooth extraction have been designed and implemented to maintain the volume of the bone and gingival tissues, which can decrease following the extraction of the teeth. In this clinical trial we will compare clinically and histologically the effectiveness of two distinct bovine bone graft materials; an allograft and a xenograft, in alveolar ridge preservation procedures following tooth extraction .
Detailed description
Patients who seek socket preservation procedures will be identified and recruited from the out clinic of College of Dentistry. Inclusion criteria will be: systemically healthy, non-smoking patients aged 21-50 years, with no bone metabolism affecting medications, good oral hygiene (full-mouth plaque score <20%), and willingness to participate. Exclusion criteria included stage III/IV periodontitis, active periodontal lesions, acute infection, severely resorbed sockets (buccal bone height <5 mm), smoking >10 cigarettes/day, and pregnancy.
Indications for extraction include caries, failed endodontic treatment, unrestorable teeth, and tooth fracture. All patients underwent full periodontal examination and initial therapy (oral hygiene instructions, scaling, and root planing) at least 4 weeks before surgery. Preoperative CBCT scans will be analyzed for baseline conditions. Reference stents will be fabricated and used to standardize bone dimensional measurements.
Sample size estimation was based on detecting a mean dimensional change in ridge width following 2-3 months of healing. With SD = 10%, α = 0.05, and power = 80%, a minimum of 9 sockets per group (18 total) was deemed adequate.
Surgical Protocol All surgical procedures will be performed under local anesthesia (2% lidocaine with 1:100,000 epinephrine). A sulcular incision will be made with a 15c blade, and atraumatic extraction will be achieved using periotomes, tooth separation, and forceps while preserving the buccal plate. Following thorough socket debridement, the buccolingual ridge width will be measured using a periodontal probe and customized stent.
Patients will be randomly allocated into one of two treatment groups:
Group 1: Allograft group (n=9) Group 2: Xenograft group (n=9) In all cases, graft material will be condensed gently from the apical region. Sockets will be covered with a collagen membrane and closed with 4-0 PTFE sutures.
All patients will receive standard postoperative care including: amoxicillin 500 mg TID for 7 days, ibuprofen 600 mg BID, and 0.12% chlorhexidine rinse BID for 7 days (starting 48h post-op). Sutures will be removed after 14 days. Patients will be recalled at 2-3 months for CBCT scans with an identical machine and settings. Buccolingual ridge width and buccal bone thickness will be assessed by superimposing baseline and follow-up scans.
At 3 months, crestal/intrasulcular incisions will be made and flaps elevated for re-entry. Biopsies will be obtained using a 2.0-mm trephine bur (8 mm length) from all grafted sites. A total of 27 biopsies (9 per group) will be collected, coded, and fixed in 10% neutral buffered formalin. Osteotomies will be completed, and implants will be placed per manufacturer protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft Group | Experimental | Procedure: Socket Preservation with Graft Material AllograftExtraction sockets grafted with cortico-cancellous particulate allograft and covered with a collagen membrane. |
| Xenograft Group | Experimental | Procedure: Socket Preservation with Graft Material AllograftExtraction sockets grafted with xenograft material and covered with a collagen membrane. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Systemically healthy individuals
Key exclusion criteria (6 listed)
- • Stage III or IV periodontitis
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 Preservation with Graft Material AllograftAlso: Socket Preservation with Graft Material XenograftSocket preservation will be performed after tooth extraction using graft material Allograft or Xenograft according to standard surgical protocol. | Procedure or surgery | Allograft Group, Xenograft Group |
Primary outcome
Change in buccolingual ridge width
Time frame: Baseline to 2-3 months
Difference in ridge width measured clinically and radiographically between baseline and 2-3 months post-extraction
1 secondary outcome
Histomorphometric outcomes
Time frame: 2-3 months
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 20 Jan 2026.
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
H Sakr, PhD principal investigator
Pharos 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 Preservation with Graft Material Allograft in people with Socket Preservation and Alveolar Ridge Augmentation, run by Pharos University in Alexandria 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 6 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 20 Jan 2026. 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?
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 Haitham Sakr, PhD (3877700, haitham.sakr@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in buccolingual ridge width (time frame: Baseline to 2-3 months). 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 20 Jan 2026.