Dental ImplantsNCT07880184
Graftless Periosteal Coverage Versus Xenogenic Graft for Jumping Gap Management in Immediate Mandibular Molar Implants
A study testing Coronally Advanced Periosteal Flap and Particulate Xenogenic Bone Graft with Collagen Membrane in people with Dental Implants, run by Horus University at 3 sites in Egypt.
Trial summary
Graftless Periosteal Coverage Versus Xenogenic Bone Graft for Jumping Gap Management in Immediate Mandibular Molar Implants. Volumetric and density bone analysis as well as the secondary aesthetic and stability outcomes were assessed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Coronally Advanced Periosteal Flap and Particulate Xenogenic Bone Graft with Collagen Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesEgypt
- Study dates
- 31 Mar 2026to 20 Oct 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Single mandibular molar immediate implant placement, with an intraoperative jumping gap ≥ 2 mm, and adequate primary implant stability (≥30 Ncm).
Who cannot join
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes), smokers, acute infection at the site, immunosuppressive therapy, severe parafunction, or poor oral hygiene (PI > 25%).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Salah Mohamed, Lecturer contact
Egypt3 sites, 1 recruiting
- Completed
Faculty of Dentistry, Horus University, Egypt
Al Mansurah, Dakahlia Governorate, 35111
- Completed
Faculty of Dentistry, Mansoura University, Egypt
Al Mansurah, Dakahlia Governorate, 35111
- Recruiting
Dental hospital of Aswan University
Aswān
About this study
Official title: Graftless Periosteal Coverage Versus Xenogenic Bone Graft Beneath a Collagen Membrane for Jumping Gap Management in Immediate Mandibular Molar Implants: A Randomized Controlled Clinical and Radiographic Trial.
Graftless Periosteal Coverage Versus Xenogenic Bone Graft for Jumping Gap Management in Immediate Mandibular Molar Implants. Volumetric and density bone analysis as well as the secondary aesthetic and stability outcomes were assessed.
Read the detailed description
Graftless Periosteal Coverage versus Xenogenic Bone Graft beneath a Collagen Membrane for Jumping Gap Management in Immediate Mandibular Molar Implants. The primary outcome of volumetric and density bone analysis as well as the secondary aesthetic and stability outcomes were assessed at 4 months. Prospective, parallel-arm, randomized controlled clinical trial.
- Conditions
- Dental Implants
- Being tested
- Coronally Advanced Periosteal Flap, Particulate Xenogenic Bone Graft with Collagen Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advanced Periosteal FlapProcedure or surgery
Immediate mandibular molar implant placement with management of the peri-implant jumping gap using a coronally advanced periosteal flap. A minimally elevated buccal full-thickness flap will be followed by a deep-to-shallow periosteal releasing incision. The periosteum will be coronally advanced to completely cover the implant shoulder and jumping gap. The gap will be left to heal under the periosteal envelope without placement of bone graft or collagen membrane, followed by tension-free primary closure.
Particulate Xenogenic Bone Graft with Collagen MembraneProcedure or surgery
Immediate mandibular molar implant placement with management of the peri-implant jumping gap using particulate xenogenic bone graft. The jumping gap will be filled with particulate xenogenic bone graft, which will be covered with a resorbable collagen membrane extending approximately 2-3 mm beyond the defect margins, followed by wound closure
| Study group | Role | What they receive |
|---|---|---|
| Mucoperiosteal Coverage | Active comparator | Immediate mandibular molar implant placement with management of the peri-implant jumping gap using a coronally advanced periosteal flap. Receives: Procedure: Coronally Advanced Periosteal Flap |
| Particulate Bone Graft & Collagen membrane | Active comparator | Immediate mandibular molar implant placement with management of the peri-implant jumping gap using particulate xenogenic bone graft. Receives: Procedure: Particulate Xenogenic Bone Graft with Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume
The volume of regenerated bone within the jumping gap surrounding the dental implant will be assessed using cone-beam computed tomography (CBCT). The regenerated bone volume will be measured in cubic millimeters (mm³) using standardized CBCT images and a predefined region of interest corresponding to the jumping gap. The volumetric measurements will be performed according to a standardized image-analysis protocol.
Measured: 4 months post-operatively
Bone density
The radiographic density of the regenerated bone surrounding the dental implant will be assessed using cone-beam computed tomography (CBCT). Bone density will be measured in Hounsfield units (HU) within a predefined region of interest corresponding to the regenerated bone around the implant. Standardized CBCT acquisition and image-analysis protocols will be used to ensure consistency of measurements.
Measured: 4 months post-operatively
Secondary outcomes (5)
Implant Stability
Measurements will be obtained using an appropriate resonance frequency analysis device at the predefined assessment time points and expressed as an implant stability quotient (ISQ). The ISQ value, ranging from 1 to 100, will be recorded for each implant, with higher ISQ values indicating greater implant stability.
For each implant, ISQ measurements will be obtained in two perpendicular directions, and the mean value will be calculated and used for statistical analysis.
Measured: Implant stability will be assessed at baseline and after 4 months
Post-operative pain
Postoperative pain will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will record their pain intensity at the specified postoperative time points.
Measured: days 2, 7, and 14 post-operative
Patient-reported post-operative swelling
Visual numeric rating scale (VNRS)/numeric scale for swelling, 0-10 numerical scale, which captures the patient's perception at 2, 7 and 14 days post-operative.
Measured: At 2, 7 and 14 days post-operative.
Postoperative complications
The occurrence of postoperative complications, including membrane exposure, flap dehiscence, and postoperative infection, will be clinically assessed at each scheduled postoperative follow-up visit. Each complication will be recorded as present or absent (yes/no), and the date of occurrence will be documented. Membrane exposure will be assessed in participants receiving the collagen membrane, while flap dehiscence and postoperative infection will be assessed in both treatment groups.
Measured: Postoperative days 2, 7, and 14, and monthly thereafter through 4 months.
Objective facial swelling
Standardized facial measurements in mm, will be measured at baseline + postoperative follow-ups. Postoperative facial swelling will be assessed using standardized facial linear measurements. Three facial distances (tragus to corner of mouth, tragus to pogonion, and angle of mandible to corner of mouth) will be measured preoperatively as baseline and postoperatively on days 2, 7 and 14 using a flexible measuring tape. All measurements will be performed by the same calibrated examiner using standardized anatomical landmarks and with the patient in a standardized seated position. The change in each facial measurement from baseline will be recorded as an objective measure of postoperative swelling.
Measured: Pre-operative (baseline), and then 2, 7 and 14 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start31 Mar 2026
- Primary completion30 Sep 2026
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Model description
- Parallel assignment, two-arm randomized controlled clinical trial. Participants will be randomly allocated in a 1:1 ratio to either periosteal coverage without graft or membrane (Test Group) or particulate xenogenic bone graft covered with a resorbable collagen membrane (Control Group) for management of the jumping gap following immediate mandibular molar implant placement. Clinical and radiographic outcomes will be assessed postoperatively at predefined follow-up intervals.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdel Salam Yousef, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880184
- Sponsor's protocol ID
- 23326
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because of ethical, privacy, and confidentiality considerations related to the limited sample size. Only aggregate, de-identified study results will be reported and made available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graftless Periosteal Coverage Versus Xenogenic Bone Graft Beneath a Collagen Membrane for Jumping Gap Management in Immediate Mandibular Molar Implants: A Randomized Controlled Clinical and Radiographic Trial.
- ClinicalTrials.gov ID
- NCT07880184
- Acronym / sponsor ID
- 23326
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 19 Oct 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.
Graftless Periosteal Coverage Versus Xenogenic Bone Graft for Jumping Gap Management in Immediate Mandibular Molar Implants. Volumetric and density bone analysis as well as the secondary aesthetic and stability outcomes were assessed.
Detailed description
Graftless Periosteal Coverage versus Xenogenic Bone Graft beneath a Collagen Membrane for Jumping Gap Management in Immediate Mandibular Molar Implants. The primary outcome of volumetric and density bone analysis as well as the secondary aesthetic and stability outcomes were assessed at 4 months. Prospective, parallel-arm, randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, two-arm randomized controlled clinical trial. Participants will be randomly allocated in a 1:1 ratio to either periosteal coverage without graft or membrane (Test Group) or particulate xenogenic bone graft covered with a resorbable collagen membrane (Control Group) for management of the jumping gap following immediate mandibular molar implant placement. Clinical and radiographic outcomes will be assessed postoperatively at predefined follow-up intervals.
| Arm | Type | Receives |
|---|---|---|
| Mucoperiosteal Coverage | Active comparator | Procedure: Coronally Advanced Periosteal FlapImmediate mandibular molar implant placement with management of the peri-implant jumping gap using a coronally advanced periosteal flap. |
| Particulate Bone Graft & Collagen membrane | Active comparator | Procedure: Particulate Xenogenic Bone Graft with Collagen MembraneImmediate mandibular molar implant placement with management of the peri-implant jumping gap using particulate xenogenic bone graft. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Single mandibular molar immediate implant placement, with an intraoperative jumping gap ≥ 2 mm, and adequate primary implant stability (≥30 Ncm).
Key exclusion criteria (1 listed)
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes), smokers, acute infection at the site, immunosuppressive therapy, severe parafunction, or poor oral hygiene (PI > 25%).
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 |
|---|---|---|
| Coronally Advanced Periosteal FlapImmediate mandibular molar implant placement with management of the peri-implant jumping gap using a coronally advanced periosteal flap. A minimally elevated buccal full-thickness flap will be followed by a deep-to-shallow periosteal releasing incision. The periosteum will be coronally advanced to completely cover the implant shoulder and jumping gap. The gap will be left to heal under the periosteal envelope without placement of bone graft or collagen membrane, followed by tension-free primary closure. | Procedure or surgery | Mucoperiosteal Coverage |
| Particulate Xenogenic Bone Graft with Collagen MembraneImmediate mandibular molar implant placement with management of the peri-implant jumping gap using particulate xenogenic bone graft. The jumping gap will be filled with particulate xenogenic bone graft, which will be covered with a resorbable collagen membrane extending approximately 2-3 mm beyond the defect margins, followed by wound closure | Procedure or surgery | Particulate Bone Graft & Collagen membrane |
Primary outcome
Bone volume
Time frame: 4 months post-operatively
The volume of regenerated bone within the jumping gap surrounding the dental implant will be assessed using cone-beam computed tomography (CBCT). The regenerated bone volume will be measured in cubic millimeters (mm³) using standardized CBCT images and a predefined region of interest corresponding to the jumping gap. The volumetric measurements will be performed according to a standardized image-analysis protocol.
Bone density
Time frame: 4 months post-operatively
The radiographic density of the regenerated bone surrounding the dental implant will be assessed using cone-beam computed tomography (CBCT). Bone density will be measured in Hounsfield units (HU) within a predefined region of interest corresponding to the regenerated bone around the implant. Standardized CBCT acquisition and image-analysis protocols will be used to ensure consistency of measurements.
5 secondary outcomes
Implant Stability
Time frame: Implant stability will be assessed at baseline and after 4 months
Post-operative pain
Time frame: days 2, 7, and 14 post-operative
Patient-reported post-operative swelling
Time frame: At 2, 7 and 14 days post-operative.
Postoperative complications
Time frame: Postoperative days 2, 7, and 14, and monthly thereafter through 4 months.
Objective facial swelling
Time frame: Pre-operative (baseline), and then 2, 7 and 14 days post-operative
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 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because of ethical, privacy, and confidentiality considerations related to the limited sample size. Only aggregate, de-identified study results will be reported and made available through publication.
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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.
Mohamed Salah Mohamed, Lecturer contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advanced Periosteal Flap and Particulate Xenogenic Bone Graft with Collagen Membrane in people with Dental Implants, run by Horus University at 3 sites 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 1 inclusion and 1 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Eman Abdel-Salam, Associate Prof (+201556767533, moonysalam1302@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone volume (time frame: 4 months post-operatively). The study lists 2 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 19 Oct 2026.