Ridge AugmentationNCT07825896
Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Posterior Atrophic Mandible
A study testing autogenous sticky bone + PRF membrane and Xenograft + collagen membrane in people with Ridge Augmentation, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- autogenous sticky bone + PRF membrane and Xenograft + collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2026to 30 Jun 2027
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing posterior mandibular teeth.
- Horizontal bone defect with width < 5.5 mm.
- Adequate zone of keratinized tissue
Who cannot join
- Presence of infection or periapical lesions in adjacent teeth.
- Medically compromised patients with a condition that affects the procedure.
- Insufficient inter-arch distance.
- Bruxism or clenching.
- Alcoholism.
- Heavy Smokers.
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
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Treatment of Posterior Atrophic Mandible (A Randomized Controlled Clinical Trial)
Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft with collagen membrane with simultaneous implant placement clinically on primary and secondary implant stability, and radiographically on bucco-lingual width gain, bone density and crestal bone loss
- Conditions
- Ridge Augmentation
- Being tested
- autogenous sticky bone + PRF membrane, Xenograft + collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous sticky bone + PRF membraneOther
Patients in this group will be treated using autogenous sticky bone with PRF membrane.
Xenograft + collagen membraneOther
Patients in this group will be treated using a xenograft with a collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: autogenous sticky bone + PRF membrane |
| Control Group | Active comparator | Not described Receives: Other: Xenograft + collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1 to 100, the higher the ISQ the higher the stability of implant
Measured: up to 6 months
change in bucco-lingual bone thickness
All participants in the study will be advised to undergo CBCT before implant placement to measure bucco-lingual bone thickness, and again 7 days postoperatively and 6 months after implant placement to assess the following.
Measured: up to 6 months
change in marginal bone level
At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest. The mean marginal bone loss after the placement of implants will be calculated by subtracting baseline value from the values obtained at 6 and 9 months post implant placement
Measured: up to 9 months
change in ridge width
Will be measured immediately and after 6 months, bone width will be measured for each implant at three levels (2, 5, and 10 mm from the alveolar crest) and the mean will be calculated for each implant at each time interval.
Measured: up to 6 months
Secondary outcomes (3)
change in pain scores
Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS). (0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe ).
Measured: up to 7 days
change in edema scores
Edema will be assessed by a descriptive 4-point scale immediately post-operative, and at the 2nd,3rd,7th days postoperatively. Measured as follows: No inflammation = none. Intra oral swelling confined to the surgical field = mild. Extra oral swelling in the surgical zone =moderate. Extra oral swelling spreading beyond the surgical zone =intense.
Measured: up to 7 days
change in bone density
Will be measured at 6 points around the implant and a mean value will be calculated
Measured: up to 6 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 2026
- Study start25 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825896
- Sponsor's protocol ID
- 1368-07/2026
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Treatment of Posterior Atrophic Mandible (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07825896
- Acronym / sponsor ID
- 1368-07/2026
- Conditions
- Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Sep 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.
Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft with collagen membrane with simultaneous implant placement clinically on primary and secondary implant stability, and radiographically on bucco-lingual width gain, bone density and crestal bone loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: autogenous sticky bone + PRF membrane |
| Control Group | Active comparator | Other: Xenograft + collagen membrane |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with missing posterior mandibular teeth.
- Horizontal bone defect with width < 5.5 mm.
- Adequate zone of keratinized tissue
Key exclusion criteria (6 listed)
- Presence of infection or periapical lesions in adjacent teeth.
- Medically compromised patients with a condition that affects the procedure.
- Insufficient inter-arch distance.
- Bruxism or clenching.
- Alcoholism.
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 |
|---|---|---|
| autogenous sticky bone + PRF membranePatients in this group will be treated using autogenous sticky bone with PRF membrane. | Other | Test Group |
| Xenograft + collagen membranePatients in this group will be treated using a xenograft with a collagen membrane. | Other | Control Group |
Primary outcome
Change in implant stability
Time frame: up to 6 months
Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1 to 100, the higher the ISQ the higher the stability of implant
change in bucco-lingual bone thickness
Time frame: up to 6 months
All participants in the study will be advised to undergo CBCT before implant placement to measure bucco-lingual bone thickness, and again 7 days postoperatively and 6 months after implant placement to assess the following.
change in marginal bone level
Time frame: up to 9 months
At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest. The mean marginal bone loss after the placement of implants will be calculated by subtracting baseline value from the values obtained at 6 and 9 months post implant placement
change in ridge width
Time frame: up to 6 months
Will be measured immediately and after 6 months, bone width will be measured for each implant at three levels (2, 5, and 10 mm from the alveolar crest) and the mean will be calculated for each implant at each time interval.
3 secondary outcomes
change in pain scores
Time frame: up to 7 days
change in edema scores
Time frame: up to 7 days
change in bone density
Time frame: up to 6 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 17 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autogenous sticky bone + PRF membrane and Xenograft + collagen membrane in people with Ridge Augmentation, run by Alexandria 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 3 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: opening soon, as of the sponsor's last update on 17 Sep 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 Mohamed Essam, BDS (01225710437, mohamedessam2363@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in implant stability (time frame: up to 6 months). 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 17 Sep 2026.