Immediate Dental ImplantNCT06519773
Modified Periosteal Inhibition With Simultaneous Implant Placement in Aesthetic Zone
A study testing Modified periosteal inhibition in people with Immediate Dental Implant, run by Tanta University at 1 site in Egypt.
Trial summary
A randomized controlled clinical and radiographic trial. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant
- What is being tested?
- Modified periosteal inhibition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Oct 2025
- 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
- Intact labial plate of bone with thickness ≤1 mm (Socket type I).
- Moderate to thick gingival phenotype.
- Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
- Presence of at least 3 mm of keratinized gingiva.
- Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.
Who cannot join
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Pregnant or lactating women.
- Smoking
- Absence of buccal plate of bone.
- History of chemotherapy, radiotherapy in head and/or neck region.
- Bisphosphonate therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Periosteal Inhibition Utilizing Bone Graft Versus Collagen Sponge With Simultaneous Implant Placement in Aesthetic Zone
A randomized controlled clinical and radiographic trial. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. These sites will be divided into two groups; each of which has ten surgical sites. After phase I therapy, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.
- Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
- After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A bone lamina 0.5 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone.
Read the detailed description
A randomized controlled clinical and radiographic trial. The purpose of the present study will be explained to the patients and informed consents will be obtained according to guidelines adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. Twenty surgical sites will be divided into two groups; each of which has ten surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE).
- Phase I therapy
- Full mouth supra and subgingival scaling and root planing will be performed to all enrolled patients. Patients will be instructed to rinse twice daily with 0.12% chlorohexidine mouth wash for 2 weeks.
- Before tooth extraction, initial radiographic records by cone beam computed tomography (CBCT) scans of the maxillary arch will be made. The pre-extraction measurements will be taken from CBCT scans to evaluate the presence of a fully intact labial plate of bone ≤1 mm. The labial plate thickness of the tooth to be extracted will be measured on cross sectional cuts at three levels below the labial bone crest: 0, 2, and 5 mm.
- Surgical technique:
- After local anathesia, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.
- Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant provided by Bego Dental Implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
- After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A soft bone lamina provided by osteobiol 0.5 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone. The cortical lamina will be fixed using Glubran 2 provided by GEM which is N-butyl 2 cyanoacrylate + Metacryloxysulfolane adhesive. The labial gap will be filled either with bone graft ( Regeinoss cortico cancelleous granules with collagen- xenograft. GRANNTIE )or collagen sponge. The socket orifice will be sealed using a customized healing abutment screwed to the implant, adequately finished, and polished to ensure a proper soft tissue emergence profile. The papilla will be sutured back using 5.0 polypropylene sling suture. For all cases, the sutures will be removed after 2 weeks.
- Postoperative Phase -All subjects will receive postoperative instructions including:
- Rinsing with 0.1% Chlorhexidine mouth rinse twice daily for two weeks.
- Antibiotics combination of 500 mg Metronidazole along with Amoxicillin Clavulanate (Augmentin 1g) every 12 hours one day preoperatively and continuing for 5 days after extraction.
- Non-steroidal anti-inflammatory (NSAID) medication of Ibuprofen 400 mg twice daily for one week.
- Conditions
- Immediate Dental Implant
- Being tested
- Modified periosteal inhibition
- Keywords
- Immediate implant, Modified periosteal inhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified periosteal inhibitionProcedure or surgery
After local anathesia, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.
- Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
- After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A soft bone lamina will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone. Then the jumping gap between the dental implant and the buccal plate of bone will be filled using either collagen sponge or xenograft.
| Study group | Role | What they receive |
|---|---|---|
| Collagen sponge group : | Sham comparator | ten sites will be treated by MPI technique+ cortical lamina membrane and collagen sponge.
The jumping gap between implant and buccal plate of bone will be filled with collagen sponge. Receives: Procedure: Modified periosteal inhibition |
| Bone graft group: | Active comparator | ten sites will be treated by MPI technique +cortical lamina membrane and xenograft collagen.
The jumping gap between implant and buccal plate of bone will be filled with xenograft collagen. Receives: Procedure: Modified periosteal inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic cone beam computed tomography (CBCT) assessment
The primary outcome of the study is to assess the amount of bone formed labial to the implant on the CBCT. This will be made by measuring bone thickness at the bone crest, 2mm and 5 mm above the crest
Measured: baseline, 6 and 12 months after implant placement.
Secondary outcomes (4)
Implant stability
The implant stability: it will be measured using the Resonance Frequency Analysis Device.
Measured: baseline and 6 months after implant placement.
Soft tissue healing
it will be recorded according to soft tissue healing index Score Clinical finding Very poor • Tissue colour: ≥50% of gingiva red
- Response to palpation: Bleeding.
- Granulation tissue: Present
- Incision margin: Not epithelialized, with loss of epithelium beyond incision margin.
- Suppuration: Present. Poor • Tissue colour: ≥50% of gingiva red.
- Response to palpation: Bleeding.
- Granulation tissue: Present.
- Incision margin: Not epithelialized, with connective tissue exposed Good • Tissue colour: ≥25% and<50% of gingiva red
- Response to palpation: No bleeding.
- Granulation tissue: None
- Incision margin: No connective tissue exposed. Very good • Tissue colour: <25% of gingiva red.
- Response to palpation: No bleeding.
- Granulation tissue: None
- Incision margin: No connective tissue exposed. Excellent • Tissue colour: All tissues pink.
- Response to palpation: No bleeding.
- Granulation tissue: None
- Incision margin: No connective tissue exposed.
Measured: within one week after surgery, 1 month and 6 months
The esthetic
it will be evaluated by pink esthetic score (PES) Variables 0 1 2 Mesial papilla Shape vs. reference tooth Absent Incomplete Complete Distal papilla Shape vs. reference tooth Absent Incomplete Complete Level of soft-tissue margin Level vs. reference tooth Major discrepancy > 2mm Minor discrepancy 1-2 mm No discrepancy < 1mm Soft-tissue contour Natural, matching reference tooth Unnatural Fairly natural Natural Alveolar process Alveolar process deficiency Obvious Slight None Soft-tissue color Color vs. reference tooth Obvious difference Moderate difference No difference Soft-tissue texture Texture vs. reference tooth Obvious difference Moderate difference No difference
- Each variable will take a score from: 2-1-0, with 2 being the best and 0 being the poorest score.
- The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth is 14 for all the seven parameters.
Measured: immediately after final prosthetic delivery and 6 months later.
Digital Assessment
Each group will be subjected to intraoral scanning at baseline, 6 and 12 months. After loading The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the vertical and horizontal linear measurement of the mucosa calculated by software.
Measured: baseline, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Dental ImplantStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Khalil Elbagoory, Tanta University
- Investigators
- Ghadeer Elbagoory, Msc, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519773
- Sponsor's protocol ID
- OMPDR 4-24 2191
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Periosteal Inhibition Utilizing Bone Graft Versus Collagen Sponge With Simultaneous Implant Placement in Aesthetic Zone
- ClinicalTrials.gov ID
- NCT06519773
- Acronym / sponsor ID
- OMPDR 4-24 2191
- Conditions
- Immediate Dental Implant
- Keywords
- Immediate implant, Modified periosteal inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 25 Jul 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.
A randomized controlled clinical and radiographic trial. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. These sites will be divided into two groups; each of which has ten surgical sites. After phase I therapy, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.
- Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
- After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A bone lamina 0.5 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone.
Detailed description
A randomized controlled clinical and radiographic trial. The purpose of the present study will be explained to the patients and informed consents will be obtained according to guidelines adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University. Twenty sites with remaining roots or non-restorable teeth in the maxillary anterior region that fulfill the inclusion criteria will be selected from the Periodontology Clinic, Faculty of Dentistry, Tanta University. Twenty surgical sites will be divided into two groups; each of which has ten surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE).
- Phase I therapy
- Full mouth supra and subgingival scaling and root planing will be performed to all enrolled patients. Patients will be instructed to rinse twice daily with 0.12% chlorohexidine mouth wash for 2 weeks.
- Before tooth extraction, initial radiographic records by cone beam computed tomography (CBCT) scans of the maxillary arch will be made. The pre-extraction measurements will be taken from CBCT scans to evaluate the presence of a fully intact labial plate of bone ≤1 mm. The labial plate thickness of the tooth to be extracted will be measured on cross sectional cuts at three levels below the labial bone crest: 0, 2, and 5 mm.
- Surgical technique:
- After local anathesia, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue.
- Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant provided by Bego Dental Implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template.
- After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A soft bone lamina provided by osteobiol 0.5 mm thickness will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone. The cortical lamina will be fixed using Glubran 2 provided by GEM which is N-butyl 2 cyanoacrylate + Metacryloxysulfolane adhesive. The labial gap will be filled either with bone graft ( Regeinoss cortico cancelleous granules with collagen- xenograft. GRANNTIE )or collagen sponge. The socket orifice will be sealed using a customized healing abutment screwed to the implant, adequately finished, and polished to ensure a proper soft tissue emergence profile. The papilla will be sutured back using 5.0 polypropylene sling suture. For all cases, the sutures will be removed after 2 weeks.
- Postoperative Phase -All subjects will receive postoperative instructions including:
- Rinsing with 0.1% Chlorhexidine mouth rinse twice daily for two weeks.
- Antibiotics combination of 500 mg Metronidazole along with Amoxicillin Clavulanate (Augmentin 1g) every 12 hours one day preoperatively and continuing for 5 days after extraction.
- Non-steroidal anti-inflammatory (NSAID) medication of Ibuprofen 400 mg twice daily for one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen sponge group : | Sham comparator | Procedure: Modified periosteal inhibitionten sites will be treated by MPI technique+ cortical lamina membrane and collagen sponge. The jumping gap between implant and buccal plate of bone will be filled with collagen sponge. |
| Bone graft group: | Active comparator | Procedure: Modified periosteal inhibitionten sites will be treated by MPI technique +cortical lamina membrane and xenograft collagen. The jumping gap between implant and buccal plate of bone will be filled with xenograft collagen. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Intact labial plate of bone with thickness ≤1 mm (Socket type I).
- Moderate to thick gingival phenotype.
- Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
- Presence of at least 3 mm of keratinized gingiva.
- Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.
Key exclusion criteria (6 listed)
- Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
- Pregnant or lactating women.
- Smoking
- Absence of buccal plate of bone.
- History of chemotherapy, radiotherapy in head and/or neck region.
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 |
|---|---|---|
| Modified periosteal inhibitionAfter local anathesia, a traumatic extraction of the hopeless tooth will be made trying as much as possible to preserve the labial plate of bone and overlying soft tissue. * Once the tooth is extracted, the socket is gently debrided and irrigated using sterile saline solution. Then the dental implant is placed in the best prosthetic driven position, following the guidelines for immediate implants using prefabricated computer guided surgical template. * After accurate implant placement, a full-thickness flap will be elevated at mesial and distal papilla making a buccal envelope. A soft bone lamina will be trimmed and hydrated in sterile saline solution for 30 s to soften it; it should be 1-2 mm larger and deeper than the vestibular bone. Then the jumping gap between the dental implant and the buccal plate of bone will be filled using either collagen sponge or xenograft. | Procedure or surgery | Bone graft group:, Collagen sponge group : |
Primary outcome
Radiographic cone beam computed tomography (CBCT) assessment
Time frame: baseline, 6 and 12 months after implant placement.
The primary outcome of the study is to assess the amount of bone formed labial to the implant on the CBCT. This will be made by measuring bone thickness at the bone crest, 2mm and 5 mm above the crest
4 secondary outcomes
Implant stability
Time frame: baseline and 6 months after implant placement.
Soft tissue healing
Time frame: within one week after surgery, 1 month and 6 months
The esthetic
Time frame: immediately after final prosthetic delivery and 6 months later.
Digital Assessment
Time frame: baseline, 6 and 12 months.
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ghadeer Elbagoory, Msc study chair
Tanta 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 Modified periosteal inhibition in people with Immediate Dental Implant, run by Tanta 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 2 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 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. Some participants in this study may receive a placebo. 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?
Radiographic cone beam computed tomography (CBCT) assessment (time frame: baseline, 6 and 12 months after implant placement.). 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 2 Oct 2026.