Periodontitis(MBL)NCT07608523
Marginal Bone Level Around Dental Implants in Periodontitis Patients
A study testing SLA Dental Implant and Plasma Spraying Dental Implant in people with Periodontitis and Dental Implants, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
This study evaluates and compares marginal bone level changes around dental implants with two different surface characteristics in patients with a history of periodontitis. Participants will receive dental implants and will be followed up for one year to assess bone level changes around the implants. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Dental Implants, Marginal Bone Loss
- What is being tested?
- SLA Dental Implant and Plasma Spraying Dental Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2023to 30 Apr 2026
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged from 35 to 55 years old, with a history of periodontitis
- Presence of at least one edentulous space
- Presence of adequate bone volume to place implants and achieves primary implant stability without the need for bone reconstructive approaches
- Absence of systemic diseases
Who cannot join
- Presence of para-functional habits
- Chronic smokers or former smokers
- Pregnancy and lactation
- Any patient who is not willing to follow our treatment protocol
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate
About this study
Official title: Evaluation of Marginal Bone Level Around Dental Implants With Two Types of Surface Characteristics in Periodontitis Patients
This study evaluates and compares marginal bone level changes around dental implants with two different surface characteristics in patients with a history of periodontitis. Participants will receive dental implants and will be followed up for one year to assess bone level changes around the implants.
Read the detailed description
Patients with treated periodontitis who require dental implants will be divided into two groups based on implant surface type. Marginal bone level will be assessed radiographically at baseline, then at 3 months,6 months, and 12 months after implant placement. The study aims to determine whether implant surface characteristics influence marginal bone loss in periodontitis-susceptible patients over a one-year follow-up period.
- Conditions
- Periodontitis, Dental Implants, Marginal Bone Loss, Periodontal Probing Depth, Gingival Inflammation
- Being tested
- SLA Dental Implant, Plasma Spraying Dental Implant
- Keywords
- SLA implant, Plasma spraying implant, Peri-implant bone, Periodontitis patients, Implant surface, Probing Depth, Gingival Index
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLA Dental ImplantDevice
Sandblasted large-grit corundum and acid-etched (SLA) surface dental implant
Plasma Spraying Dental ImplantDevice
Plasma spraying surface treated dental implant
| Study group | Role | What they receive |
|---|---|---|
| Group I - Periodontitis SLA | Experimental | 15 periodontitis patients receiving SLA surface implants Receives: Device: SLA Dental Implant |
| Group II - Periodontitis Plasma | Experimental | 15 periodontitis patients receiving plasma spraying surface treated implants Receives: Device: Plasma Spraying Dental Implant |
| Group III - Healthy SLA | Active comparator | 5 periodontally healthy patients receiving SLA surface implants Receives: Device: SLA Dental Implant |
| Group IV - Healthy Plasma | Active comparator | 5 periodontally healthy patients receiving plasma spraying surface treated implants Receives: Device: Plasma Spraying Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level
Radiographic assessment of marginal bone level changes around dental implants measured in millimeters using Cone Beam Computed Tomography (CBCT)
Measured: Baseline, 3 months, 6 months, and 12 months after implant placement
Secondary outcomes (2)
Probing Depth
probing depth measured in millimeters around implants
Measured: Baseline, 3 months, 6 months, and 12 months
Gingival Index
The gingival condition around the implants were evaluated using the Löe and Silness Gingival Index. A plastic periodontal probe were used to gently assess the gingival tissues at four surfaces per implant (mesial, buccal, distal, and lingual). Each surface was scored from 0 to 3 as follows:
0 = Normal gingiva
- = Mild inflammation (slight change in color, slight edema, no bleeding on probing)
- = Moderate inflammation (redness, edema, bleeding on probing)
- = Severe inflammation (marked redness and edema, ulceration, spontaneous bleeding)
Measured: Baseline, 3 months, 6 months, 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 posted27 May 2026
- Study start30 Apr 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Participants will be divided into four groups based on implant surface type and periodontal status: Group I: 15 periodontitis patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group II: 15 periodontitis patients receiving plasma spraying surface treated implants. Group III: 5 periodontally healthy patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group IV: 5 periodontally healthy patients receiving plasma spraying surface treated implants. All groups will be followed up for 12 months to assess marginal bone level changes radiographically.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Howida Sabry, Faculty of Dental Medicine for Girls
- Investigators
- Osama Sayed EL-Shall, Professor, Principal investigator, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, EgyptLobna Mohamed Abd-ELaziz, Associate Professor, Study director, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608523
- Sponsor's protocol ID
- AZHAR-OMPDR_103_2i-2023
- Acronym
- (MBL)
- Status last verified
- Apr 2023
- First submitted
- 20 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Bone Level Around Dental Implants With Two Types of Surface Characteristics in Periodontitis Patients
- ClinicalTrials.gov ID
- NCT07608523
- Acronym / sponsor ID
- (MBL) / AZHAR-OMPDR_103_2i-2023
- Conditions
- Periodontitis, Dental Implants, Marginal Bone Loss, Periodontal Probing Depth, Gingival Inflammation
- Keywords
- SLA implant, Plasma spraying implant, Peri-implant bone, Periodontitis patients, Implant surface, Probing Depth, Gingival Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 May 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.
This study evaluates and compares marginal bone level changes around dental implants with two different surface characteristics in patients with a history of periodontitis. Participants will receive dental implants and will be followed up for one year to assess bone level changes around the implants.
Detailed description
Patients with treated periodontitis who require dental implants will be divided into two groups based on implant surface type. Marginal bone level will be assessed radiographically at baseline, then at 3 months,6 months, and 12 months after implant placement. The study aims to determine whether implant surface characteristics influence marginal bone loss in periodontitis-susceptible patients over a one-year follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be divided into four groups based on implant surface type and periodontal status: Group I: 15 periodontitis patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group II: 15 periodontitis patients receiving plasma spraying surface treated implants. Group III: 5 periodontally healthy patients receiving sandblasted large-grit corundum and acid-etched (SLA) surface implants. Group IV: 5 periodontally healthy patients receiving plasma spraying surface treated implants. All groups will be followed up for 12 months to assess marginal bone level changes radiographically.
| Arm | Type | Receives |
|---|---|---|
| Group I - Periodontitis SLA | Experimental | Device: SLA Dental Implant15 periodontitis patients receiving SLA surface implants |
| Group II - Periodontitis Plasma | Experimental | Device: Plasma Spraying Dental Implant15 periodontitis patients receiving plasma spraying surface treated implants |
| Group III - Healthy SLA | Active comparator | Device: SLA Dental Implant5 periodontally healthy patients receiving SLA surface implants |
| Group IV - Healthy Plasma | Active comparator | Device: Plasma Spraying Dental Implant5 periodontally healthy patients receiving plasma spraying surface treated implants |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged from 35 to 55 years old, with a history of periodontitis
- Presence of at least one edentulous space
- Presence of adequate bone volume to place implants and achieves primary implant stability without the need for bone reconstructive approaches
- Absence of systemic diseases
Key exclusion criteria (4 listed)
- Presence of para-functional habits
- Chronic smokers or former smokers
- Pregnancy and lactation
- Any patient who is not willing to follow our treatment protocol
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 |
|---|---|---|
| SLA Dental ImplantSandblasted large-grit corundum and acid-etched (SLA) surface dental implant | Device | Group I - Periodontitis SLA, Group III - Healthy SLA |
| Plasma Spraying Dental ImplantPlasma spraying surface treated dental implant | Device | Group II - Periodontitis Plasma, Group IV - Healthy Plasma |
Primary outcome
Marginal Bone Level
Time frame: Baseline, 3 months, 6 months, and 12 months after implant placement
Radiographic assessment of marginal bone level changes around dental implants measured in millimeters using Cone Beam Computed Tomography (CBCT)
2 secondary outcomes
Probing Depth
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival Index
Time frame: Baseline, 3 months, 6 months, 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 16 Jun 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. This study is not recruiting at the moment.
Osama Sayed EL-Shall, Professor principal investigator
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
Lobna Mohamed Abd-ELaziz, Associate Professor study director
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLA Dental Implant and Plasma Spraying Dental Implant in people with Periodontitis and Dental Implants, 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 4 inclusion and 4 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 16 Jun 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?
Marginal Bone Level (time frame: Baseline, 3 months, 6 months, 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 16 Jun 2026.