Ridge PreservationNCT06896097
Ridge Preservation Using Collagen Sponge Alone or Combined with Xenograft: a Clinical and Histological Trial
A study testing Ridge preservation in people with Ridge Preservation, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
24 patients had a treatment plan for extraction of non restorable single rooted maxillary tooth and will be subjected to one of three groups after tooth extraction Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation
- What is being tested?
- Ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2022to 2 Jan 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with a single rooted maxillary tooth that had a treatment plan of extraction as; endodontic complication, root fracture, trauma, or advanced carious lesions.
- Teeth with or without periapical lesions not affecting buccal wall integrity.
- Patients age (18 - 60) years old.
- Patients with clinical periodontal health on an intact periodontium and adequate volume that allow for implant placement after follow-up period.
- Pristine extraction socket (type I socket).
Who cannot join
- Patients with any systemic condition that may affect surgical and healing process.
- Patients with active acute infection related to teeth of interest.
- Pregnant females.
- History of malignancy or radiotherapy for malignancy in the past 5 years.
- History of active bone metabolic disease.
- Patients taking or were taking medications that may affect bone turnover such as bisphosphonates.
Show all 9Show fewer
- Patients with buccal bone thickness less than 1 mm that necessitate regeneration and flap elevation. 7
- Smoker patients who reported tobacco use in the past 5 years.
- The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls
Cairo, Cairo Governorate, 11511
About this study
24 patients had a treatment plan for extraction of non restorable single rooted maxillary tooth and will be subjected to one of three groups after tooth extraction Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge alone and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
Read the detailed description
- Surgical Phase:
- Local infiltration anesthesia will be first administered to all patients in this study.
- Teeth will be extracted, using a flapless approach a traumatically as much as possible.
- Atraumatic extraction will start with dissection of periodontal ligaments in crestal part using 15C blades mounted over a round-handed blade to facilitate rotation without lacerating the soft tissue
- Then teeth will be luxated using micro-elevators and the final delivery movement will be done using forceps.
- Sockets will be thoroughly debrided using a curette, especially in case with periapical lesions, to ensure complete removal of granulation tissue.
- Assessment of sockets walls integrity will be done visually and using a UNC-15 periodontal probe. All patients will be allocated into one of the three study groups. Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
- Conditions
- Ridge Preservation
- Being tested
- Ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge preservationProcedure or surgery
extraction of non restorable tooth in a traumatic way and socket preservation with the selected group
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge (deep collagen layer) and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket and socket sealing will be performed with a new layer of collagen sponge (superficial collagen layer) and criss-cross suture to stabilize the graft in place Receives: Procedure: Ridge preservation |
| Group II | Experimental | including 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture Receives: Procedure: Ridge preservation |
| Group III | Experimental | control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss -cross suture Receives: Procedure: Ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological
evaluate and compare the clinical outcomes to width and height of socket preservation using the Biologically-oriented Alveolar Ridge Preservation (BARP) versus Collagen Sponge (CS), all compared to negative control
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start2 Aug 2022
- Primary completion29 Jul 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program, patients will be subjected to extraction of primary maxillary single rooted tooth and socket preservation will be done by collagen sponge alone or combined with xenograft
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeinab Shalaby, Faculty of Dental Medicine for Girls
- Investigators
- Zienab Shalaby, Principal investigator, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896097
- Sponsor's protocol ID
- P-ME-21-06
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Using Collagen Sponge Alone or Combined with Xenograft: a Clinical and Histological Trial
- ClinicalTrials.gov ID
- NCT06896097
- Acronym / sponsor ID
- P-ME-21-06
- Conditions
- Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 26 Mar 2025 (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.
24 patients had a treatment plan for extraction of non restorable single rooted maxillary tooth and will be subjected to one of three groups after tooth extraction Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge alone and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
Detailed description
- Surgical Phase:
- Local infiltration anesthesia will be first administered to all patients in this study.
- Teeth will be extracted, using a flapless approach a traumatically as much as possible.
- Atraumatic extraction will start with dissection of periodontal ligaments in crestal part using 15C blades mounted over a round-handed blade to facilitate rotation without lacerating the soft tissue
- Then teeth will be luxated using micro-elevators and the final delivery movement will be done using forceps.
- Sockets will be thoroughly debrided using a curette, especially in case with periapical lesions, to ensure complete removal of granulation tissue.
- Assessment of sockets walls integrity will be done visually and using a UNC-15 periodontal probe. All patients will be allocated into one of the three study groups. Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program, patients will be subjected to extraction of primary maxillary single rooted tooth and socket preservation will be done by collagen sponge alone or combined with xenograft
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Ridge preservationincluding 8 patients, preservation of extraction sockets will be done with combination of collagen sponge (deep collagen layer) and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket and socket sealing will be performed with a new layer of collagen sponge (superficial collagen layer) and criss-cross suture to stabilize the graft in place |
| Group II | Experimental | Procedure: Ridge preservationincluding 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture |
| Group III | Experimental | Procedure: Ridge preservationcontrol group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss -cross suture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a single rooted maxillary tooth that had a treatment plan of extraction as; endodontic complication, root fracture, trauma, or advanced carious lesions.
- Teeth with or without periapical lesions not affecting buccal wall integrity.
- Patients age (18 - 60) years old.
- Patients with clinical periodontal health on an intact periodontium and adequate volume that allow for implant placement after follow-up period.
- Pristine extraction socket (type I socket).
Key exclusion criteria (9 listed)
- Patients with any systemic condition that may affect surgical and healing process.
- Patients with active acute infection related to teeth of interest.
- Pregnant females.
- History of malignancy or radiotherapy for malignancy in the past 5 years.
- History of active bone metabolic disease.
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 |
|---|---|---|
| Ridge preservationextraction of non restorable tooth in a traumatic way and socket preservation with the selected group | Procedure or surgery | Group I, Group II, Group III |
Primary outcome
Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological
Time frame: 4 months
evaluate and compare the clinical outcomes to width and height of socket preservation using the Biologically-oriented Alveolar Ridge Preservation (BARP) versus Collagen Sponge (CS), all compared to negative control
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 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Ridge Preservation
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
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.
Zienab Shalaby principal investigator
Faculty of Dental Medicine for Girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge preservation in people with Ridge Preservation, run by Faculty of Dental Medicine for Girls 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 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: finished, as of the sponsor's last update on 26 Mar 2025. 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?
Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological (time frame: 4 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 26 Mar 2025.