Socket PreservationNCT06318650
Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft
A study testing Demineralized Dentin Matrix and Demineralized freeze-dried bone allograft (DFDBA) in people with Socket Preservation, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Demineralized Dentin Matrix and Demineralized freeze-dried bone allograft (DFDBA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients between the age of 20-55.
- Single rooted, non-restorable or hopeless tooth with adjacent teeth.
- Extraction socket with no more than 50% buccal bone loss
- Patients accept 6-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Who cannot join
- Patients with uncontrolled systemic disease.
- Patient with severe para-functional habits.
- Patients with poor maintenance of oral hygiene.
- Pregnancy.
- Smokers.
- Patients taking any medications that could compromise healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation in the Esthetic Zone Using Allogeneic Dentin Matrix Versus Demineralized Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial
the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.
Read more
Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing technique
Intervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).
For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability.
Read the detailed description
This study aims to evaluate clinical, radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) in alveolar ridge preservation after tooth extraction in the esthetic zone.
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University.
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
surgical interventions: Atraumatic extraction.The patient will rinse their mouth with 0.12% Chlorhexidine Administration of 4% articaine hydrochloride with 1:100,000 epinephrine will be as local anesthetic agent.Flapless and atraumatic tooth extraction will be initiated, using 15C blade intrasulcular incision will be performed.A periotome will be utilized to sever the periodontal ligament (PDL) fibers, followed by extraction witha straight elevator and extraction forceps.
Test group:
preparation of Allogenic Demineralized Dentin Matrix. Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps
- (Washing with Distilled water for 30-120 mins) The dental root that has had its soft and pulp tissues removed is cleaned with distilled water for anywhere between 30 minutes and two hours. The dental root includes residual dentin and cementum, even though soft and pulp tissues have been removed.
- (Quick Freezing with liquid nitrogen -160 o C for 30-120 mins Then Grinding to particle size of 300- 800 μm) The dental root is processed into powder by quick-freezing and crushing, the same method used for the dental crown, with an average particle diameter of 200 mm to 1,500 mm. To eliminate impurities and remaining soft tissue, the powder will be washed with distilled water for 30 minutes to 2 hours.
- (Ultrasonic Cleaning cycles, 1st with Distilled water for 5-10 mins, 2nd with 5-7% Hydrogen Perioxide10-30 mins then 3rd with Distilled water for 5-10 mins at 60-80 o) Each cycle of ultrasonic cleaning includes: a first washing step in which the powder is processed with ultrasonic cleaning for about 5 minutes to about 10 minutes in pure water or sterilized distilled water; a second washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution; and a third washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution. The concentration of the hydrogen peroxide solution is around 5% to 7%, the volume of the washing fluid of each washing step is approximately 5 times to approximately 10 times that of the powder, and the temperature of the washing fluid may be approximately 60°C to 80°C.
- (Defatting with Chloroform Methanol Solution1:0.5 for 3-12 hours) The powder cleaned in the preceding step can be largely degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of about 1:0.5 to about 1:2 for 3 to 12 hours. The largely degreased powder can be centrifuged to remove floating fat and rinsed with distilled water for at least 1 hour.
- (Demineralization with0.5N HCL for 10-60 mins) For about 10 minutes to about 1 hour, the principally degreased powder is delimed (Demineralized) with about 0.5N hydrochloric acid aqueous solution whose volume is about 5 times to about 10 times that of the powder.
- (Dehydration with Neutral Ethyl Alcohol for 30 mins then Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours) The delimed powder is next dehydrated with neutral ethyl alcohol for 30 minutes to 2 hours. The dehydrated powder can be secondary degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of approximately 1:0.5 to about 1:2 for 3 to 12 hours.
- (Washing with Normal Saline \& Freeze Drying then Sterilization using Ethylene oxide gas) The above-mentioned powder is degreased, delimed, and dehydrated before being post-treated with the steps of washing with normal saline solution and freeze-drying the degreased, delimed, and dehydrated powder; and sterilization will be done using ethylene oxide gas.
Alveolar ridge preservation:
- Following extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.
- Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) in control group up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered.
Postoperative Care and follow up:
- Participants will be instructed to avoid causing any damage to the operated site, to prevent interfering with the sutures, and to avoid consuming hot meals or vigorous rinsing.
- They will be encouraged to continue cleaning their teeth, only avoiding the operated site. Moderate tooth brushing for the operation site will be recommended after two weeks.
- Participants will be given Amoxicillin 500 mg three times a day for seven days, or doxycycline 100 mg twice a day if they are penicillin sensitive.
- Ibuprofen 600 mg will be provided for severe pain.
- Participants will be asked to use a 0.12% Chlorhexidine mouthwash twice daily for two weeks to assist gentle rinsing.
- Sutures will be removed two weeks after the surgery.
- A baseline cone-beam computed tomography (CBCT) scan will be conducted on the same day postoperative. A final follow-up visits and CBCT scan will be scheduled for six months postoperative to evaluate the dimensions of the alveolus before implant placement.
Biopsy collection After a 6-months healing period, a biopsy will be collected from the central area of the grafted site with a 3- mm trephine bur at the time of implant implantation. The biopsy will be immediately fixed in 10% neutral buffered formalin, followed by dehydration in a series of increasing concentration alcohol baths (varying from 50% to 100%). The specimen will then be encased in paraffin. Finally, a 4 m thick tissue section will be cut and stained with hematoxylin and eosin for subsequent histological investigation.
- Conditions
- Socket Preservation
- Being tested
- Demineralized Dentin Matrix, Demineralized freeze-dried bone allograft (DFDBA)
- Keywords
- Socket preservation, Ridge preservation, Allogeneic dentin matrix, Demineralized freeze dried bone allograft, DFDBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demineralized Dentin MatrixBiological
preparation of Allogenic Demineralized Dentin Matrix: Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps
- (Washing with Distilled water ) 2. (Quick Freezing with liquid nitrogen, then Grinding to particle size of 300- 800 μm). 3.(Ultrasonic Cleaning cycles, 1st with Distilled water , 2nd with 5-7% Hydrogen Perioxide then 3rd with Distilled water for at 60-80 o) 4. (Defatting with Chloroform Methanol Solution1:0.5. 5. (Demineralization with0.5N HCL) 6. (Dehydration with Neutral Ethyl Alcohol then Defatting with Chloroform Methanol Solution 1:0.5 for ) 7. (Washing with Normal Saline \& Freeze Drying then Sterilization using Ethylene oxide gas).
Demineralized freeze-dried bone allograft (DFDBA)Biological
combination allograft, is a particulate bone graft combining 70% mineralized ground cortical with 30% demineralized ground cortical Particle sizing: 250 - 1000um.
| Study group | Role | What they receive |
|---|---|---|
| Allogenic Demineralized Dentin Matrix | Experimental | Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Allogeneic Dentin Matrix (that has been prepared before) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. Receives: Biological: Demineralized Dentin Matrix |
| Demineralized Freeze-Dried Bone Allograft | Active comparator | Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Demineralized freeze-dried bone allograft (DFDBA) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. Receives: Biological: Demineralized freeze-dried bone allograft (DFDBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ridge width over 6 months
Before surgical intervention, baseline and 6-month postoperative examination will be conducted. Before surgical procedure ridge width will be measured using caliper, a resin acrylic stent will be placed measurements of 3mm and 5mm from gingival margin will be marked and measures the ridge width through it, this will be repeated after extraction (baseline) and 6 months postoperative.
Measured: after 6 months postoperatively
Secondary outcomes (4)
Change in the radiographic vertical bone level
Baseline and 6-month postoperative CBCT scans will be conducted. At both time points, measurements will be taken with identical reference points and lines. The most apical point of the extraction socket will be determined on the baseline image, and two reference lines will be created to form a reference. The vertical reference line will cross the apical reference point at the midway of the extraction socket.The alveolus' height will be measured at the midbuccal aspect (BH) and the midlingual aspect (LH).
Measured: after 6 months postoperatively
Change in the radiographic horizontal bone level
CBCT scans will be performed at baseline and 6 months thereafter. At both time points, measurements will be taken with identical reference points and lines. The most apical point of the extraction socket will be determined on the baseline image, and two reference lines will be created to form a reference. The vertical reference line will cross the apical reference point at the midway of the extraction socket. In addition, a horizontal reference line perpendicular to the vertical line will be drawn, passing through the apical reference point.The horizontal ridge width will be measured at three different levels: 1 mm, 3 mm, and 5 mm below the crest's most coronal aspect. These measurements will be denoted by the letters HW-1, HW-3, and HW-5.
Measured: after 6 months postoperatively
Percentage of new vital bone formation and residual graft
The biopsies will be preserved in a 10% formalin solution. Following that, they will undergo four weeks of EDTA decalcification. The specimens will be treated and embedded in paraffin after decalcification to generate tissue blocks. The paraffin blocks will be split into longitudinal sections of 5m thickness. For histological examination and histomorphometric analysis, these slices will be stained with hematoxylin and eosin (H\&E) or Masson's trichromatic (MT) stains. A digital light microscope will be used to photograph the stained sections.
Measured: after 6 months postoperatively
Implant Primary Stability
The Osstell Mentor Resonance Frequency Analyzer (Osstell AB, Goteborg, Sweden) will be used to evaluate the primary stability of the implant fixture. For each implant, two measurements will be collected in the buccolingual and mesiodistal directions. The representative implant stability quotient (ISQ) for each particular implant will be calculated as the average of these two measurements.
Measured: after 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Mubarak Saleem Bin Nuhaid, Cairo University
- Investigators
- Manal M. Hosny, Professor, Study director, Cairo UniversityFatima M. Saleem Bin Nuhaid, Bachelor, Principal investigator, Cairo UniversityWeam A. El-Battawy Study Chair, Ass. Prof., Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318650
- Sponsor's protocol ID
- 19124PER6_3_1
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation in the Esthetic Zone Using Allogeneic Dentin Matrix Versus Demineralized Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06318650
- Acronym / sponsor ID
- 19124PER6_3_1
- Conditions
- Socket Preservation
- Keywords
- Socket preservation, Ridge preservation, Allogeneic dentin matrix, Demineralized freeze dried bone allograft, DFDBA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Mar 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.
the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.
Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing technique
Intervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).
For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability.
Detailed description
This study aims to evaluate clinical, radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) in alveolar ridge preservation after tooth extraction in the esthetic zone.
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University.
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
surgical interventions: Atraumatic extraction.The patient will rinse their mouth with 0.12% Chlorhexidine Administration of 4% articaine hydrochloride with 1:100,000 epinephrine will be as local anesthetic agent.Flapless and atraumatic tooth extraction will be initiated, using 15C blade intrasulcular incision will be performed.A periotome will be utilized to sever the periodontal ligament (PDL) fibers, followed by extraction witha straight elevator and extraction forceps.
Test group:
preparation of Allogenic Demineralized Dentin Matrix. Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps
- (Washing with Distilled water for 30-120 mins) The dental root that has had its soft and pulp tissues removed is cleaned with distilled water for anywhere between 30 minutes and two hours. The dental root includes residual dentin and cementum, even though soft and pulp tissues have been removed.
- (Quick Freezing with liquid nitrogen -160 o C for 30-120 mins Then Grinding to particle size of 300- 800 μm) The dental root is processed into powder by quick-freezing and crushing, the same method used for the dental crown, with an average particle diameter of 200 mm to 1,500 mm. To eliminate impurities and remaining soft tissue, the powder will be washed with distilled water for 30 minutes to 2 hours.
- (Ultrasonic Cleaning cycles, 1st with Distilled water for 5-10 mins, 2nd with 5-7% Hydrogen Perioxide10-30 mins then 3rd with Distilled water for 5-10 mins at 60-80 o) Each cycle of ultrasonic cleaning includes: a first washing step in which the powder is processed with ultrasonic cleaning for about 5 minutes to about 10 minutes in pure water or sterilized distilled water; a second washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution; and a third washing step in which the powder is processed with ultrasonic cleaning for about 10 minutes to about 30 minutes in hydrogen peroxide solution. The concentration of the hydrogen peroxide solution is around 5% to 7%, the volume of the washing fluid of each washing step is approximately 5 times to approximately 10 times that of the powder, and the temperature of the washing fluid may be approximately 60°C to 80°C.
- (Defatting with Chloroform Methanol Solution1:0.5 for 3-12 hours) The powder cleaned in the preceding step can be largely degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of about 1:0.5 to about 1:2 for 3 to 12 hours. The largely degreased powder can be centrifuged to remove floating fat and rinsed with distilled water for at least 1 hour.
- (Demineralization with0.5N HCL for 10-60 mins) For about 10 minutes to about 1 hour, the principally degreased powder is delimed (Demineralized) with about 0.5N hydrochloric acid aqueous solution whose volume is about 5 times to about 10 times that of the powder.
- (Dehydration with Neutral Ethyl Alcohol for 30 mins then Defatting with Chloroform Methanol Solution 1:0.5 for 3-12 hours) The delimed powder is next dehydrated with neutral ethyl alcohol for 30 minutes to 2 hours. The dehydrated powder can be secondary degreased using a chloroform methanol solution with a chloroform to methanol weight ratio of approximately 1:0.5 to about 1:2 for 3 to 12 hours.
- (Washing with Normal Saline \& Freeze Drying then Sterilization using Ethylene oxide gas) The above-mentioned powder is degreased, delimed, and dehydrated before being post-treated with the steps of washing with normal saline solution and freeze-drying the degreased, delimed, and dehydrated powder; and sterilization will be done using ethylene oxide gas.
Alveolar ridge preservation:
- Following extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.
- Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) in control group up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered.
Postoperative Care and follow up:
- Participants will be instructed to avoid causing any damage to the operated site, to prevent interfering with the sutures, and to avoid consuming hot meals or vigorous rinsing.
- They will be encouraged to continue cleaning their teeth, only avoiding the operated site. Moderate tooth brushing for the operation site will be recommended after two weeks.
- Participants will be given Amoxicillin 500 mg three times a day for seven days, or doxycycline 100 mg twice a day if they are penicillin sensitive.
- Ibuprofen 600 mg will be provided for severe pain.
- Participants will be asked to use a 0.12% Chlorhexidine mouthwash twice daily for two weeks to assist gentle rinsing.
- Sutures will be removed two weeks after the surgery.
- A baseline cone-beam computed tomography (CBCT) scan will be conducted on the same day postoperative. A final follow-up visits and CBCT scan will be scheduled for six months postoperative to evaluate the dimensions of the alveolus before implant placement.
Biopsy collection After a 6-months healing period, a biopsy will be collected from the central area of the grafted site with a 3- mm trephine bur at the time of implant implantation. The biopsy will be immediately fixed in 10% neutral buffered formalin, followed by dehydration in a series of increasing concentration alcohol baths (varying from 50% to 100%). The specimen will then be encased in paraffin. Finally, a 4 m thick tissue section will be cut and stained with hematoxylin and eosin for subsequent histological investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Allogenic Demineralized Dentin Matrix | Experimental | Biological: Demineralized Dentin MatrixFollowing atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Allogeneic Dentin Matrix (that has been prepared before) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. |
| Demineralized Freeze-Dried Bone Allograft | Active comparator | Biological: Demineralized freeze-dried bone allograft (DFDBA)Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Demineralized freeze-dried bone allograft (DFDBA) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients between the age of 20-55.
- Single rooted, non-restorable or hopeless tooth with adjacent teeth.
- Extraction socket with no more than 50% buccal bone loss
- Patients accept 6-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Key exclusion criteria (6 listed)
- Patients with uncontrolled systemic disease.
- Patient with severe para-functional habits.
- Patients with poor maintenance of oral hygiene.
- Pregnancy.
- Smokers.
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 |
|---|---|---|
| Demineralized Dentin Matrixpreparation of Allogenic Demineralized Dentin Matrix: Extracted teeth will be collected from the Departments of oral maxillofacial surgery and periodontics, Cairo university. Cleaning the teeth from any caries, Filings, cement, tartar, soft tissue debris and prosthetic components will be performed using a diamond bur under abundant irrigation with physiological water. Then it will be proceeded to the following steps 1. (Washing with Distilled water ) 2. (Quick Freezing with liquid nitrogen, then Grinding to particle size of 300- 800 μm). 3.(Ultrasonic Cleaning cycles, 1st with Distilled water , 2nd with 5-7% Hydrogen Perioxide then 3rd with Distilled water for at 60-80 o) 4. (Defatting with Chloroform Methanol Solution1:0.5. 5. (Demineralization with0.5N HCL) 6. (Dehydration with Neutral Ethyl Alcohol then Defatting with Chloroform Methanol Solution 1:0.5 for ) 7. (Washing with Normal Saline \& Freeze Drying then Sterilization using Ethylene oxide gas). | Biological | Allogenic Demineralized Dentin Matrix |
| Demineralized freeze-dried bone allograft (DFDBA)combination allograft, is a particulate bone graft combining 70% mineralized ground cortical with 30% demineralized ground cortical Particle sizing: 250 - 1000um. | Biological | Demineralized Freeze-Dried Bone Allograft |
Primary outcome
Change in Ridge width over 6 months
Time frame: after 6 months postoperatively
Before surgical intervention, baseline and 6-month postoperative examination will be conducted. Before surgical procedure ridge width will be measured using caliper, a resin acrylic stent will be placed measurements of 3mm and 5mm from gingival margin will be marked and measures the ridge width through it, this will be repeated after extraction (baseline) and 6 months postoperative.
4 secondary outcomes
Change in the radiographic vertical bone level
Time frame: after 6 months postoperatively
Change in the radiographic horizontal bone level
Time frame: after 6 months postoperatively
Percentage of new vital bone formation and residual graft
Time frame: after 6 months postoperatively
Implant Primary Stability
Time frame: after 6 months postoperatively
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 1 Jul 2026.
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Recruiting
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. This study is not recruiting at the moment.
Manal M. Hosny, Professor study director
Cairo University
Fatima M. Saleem Bin Nuhaid, Bachelor principal investigator
Cairo University
Weam A. El-Battawy Study Chair, Ass. Prof. study chair
Cairo 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 Demineralized Dentin Matrix and Demineralized freeze-dried bone allograft (DFDBA) in people with Socket Preservation, 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 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: finished, as of the sponsor's last update on 1 Jul 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?
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?
Change in Ridge width over 6 months (time frame: after 6 months postoperatively). 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 1 Jul 2026.