PeriodontitisNCT07688408
Short Implants in Unitary Implant-supported Rehabilitations in the Posterior Maxilla and Mandible: 5 Years of Follow-up
An observational study of Periodontitis and Periodontal Disease, run by University of Guarulhos at 1 site in Brazil.
Trial summary
Implant-supported rehabilitation of regions with severe bone resorption is a challenge for implant dentists. Structures such as the maxillary sinus and the inferior alveolar canal often make it impossible to use implants of lengths considered standard in the literature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Disease
- What is being tested?
- bone loss
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jun 2026to 28 Feb 2027
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals (> 21 years old), of both sexes, specifically rehabilitated with morse connection implants (Implacil De Bortoli, São Paulo, SP, Brazil) in the posterior region of the jaws for single-sided unsupported restorations, will be included in this study. Individuals will also need to have at least initial radiographic controls (immediately after implant placement) and 12 and 60 months of follow-up after implant placement. Individuals will be included in the population sample, with the following criteria observed: location, implant installation region, implant diameter, and adaptation.
Who may be able to join
- Individuals (> 21 years old), of both sexes, specifically rehabilitated with morse connection implants (Implacil De Bortoli, São Paulo, SP, Brazil) in the posterior region of the jaws for single-sided unsupported restorations, will be included in this study. Individuals will also need to have at least initial radiographic controls (immediately after implant placement) and 12 and 60 months of follow-up after implant placement. Individuals will be included in the population sample, with the following criteria observed: location, implant installation region, implant diameter, and adaptation.
Who cannot join
- Immediate implants will be excluded, individuals with clinical records who, throughout the study, do not have radiographs for evaluation and/or radiographs of poor quality that make radiographic measurements impossible; medical records with insufficient data, filled out inappropriately or that indicate doubt about the details of the procedure performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short Implants (7 and 8 mm) in Unitary Implant-supported Rehabilitations in the Posterior Sector of the Maxilla and Mandible: 5 Years of Follow-up
Implant-supported rehabilitation of regions with severe bone resorption is a challenge for implant dentists. Structures such as the maxillary sinus and the inferior alveolar canal often make it impossible to use implants of lengths considered standard in the literature. The use of short 7 and 8 mm implants with new macrogeometries and surface treatments, in addition to the application of Morse taper prosthetic connections, has shown results that increasingly encourage their use. However, the longevity of these rehabilitations needs to be constantly evaluated. In this work, unitary implant-supported rehabilitations in the posterior jaws, supported by short (7 and 8 mm) tapered Morse connection implants, will be followed for a period of 5 years. A total of 100 subjects rehabilitated with tapered Morse connection implants, with diameters between 3.5 and 4.5 mm, will be evaluated. Peri-implant bone remodeling, implant stability measured through ISQ and clinical parameters will be evaluated per implant and over the evaluation time. Periapical radiographs will be obtained and digitized, analyzed by software and compared with the initial data. The data obtained will be analyzed, allowing longitudinal evaluations and the success rate of implant restorations supported by short implants.
Read the detailed description
3.3. Clinical examinations A single, trained and calibrated examiner will perform all clinical examinations. The examiner will be trained and calibrated before and during the study in order to achieve maximum reproducibility in measurements. The methodology to be used for intra-examiner calibration will be the one recommended by Araujo et al. 2003, in which the standard error of measurement for continuous periodontal clinical parameters (SP and CIN) is evaluated. For the other clinical variables, the mean level of agreement between the examiners will be determined and considered satisfactory when the value is greater than 90% (Kappa test).
Clinical measures
The following parameters will be recorded at six sites per implant using a periodontal probe North Carolina (Hu-Friedy, Chicago, IL, USA):
- Plate index (PI): 0 = absence of plaque; 1 = separate patches of plaque at the cervical margin; 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; 3 = strip of plaque greater than 1 mm, but covering less than 1/3 of the tooth crown; 4 = plaque that covers at least 1/3 but less than 2/3 of the tooth's crown; 5 = plate covering 2/3 or more of the tooth's crown).
- Gingival index (GI): 0 = absence of inflammation; 1 = mild inflammation change in color and little change in texture; 2 = moderate inflammation - tempered glasses, redness, edema and hypertrophy; 3 = severe inflammation - marked redness and hyperplasia.
- Bleeding on probing (SS): 0 = absence; 1 = presence.
- Suppuration (Sup): 0 = absence; 1 = presence.
- Probing depth (PS): distance (mm) from the peri-implant mucosal margin to the most apical portion of the peri-implant pocket.
- Relative attachment level (NI): distance (mm) from the implant shoulder to the most apical portion of the peri-implant pocket.
- Keratinized tissue height (THA): vertical distance (mm) measured from the mucogingival line to the peri-implant margin in the center of the buccal face of the implant.
- Keratinized tissue thickness 1 (ETQ1): measured in the center of the buccal surface of the ridge, at the midpoint between the mucogingival line and the top of the ridge.
- Mesial and distal keratinized tissue thickness 2 (ETQ2M, ETQ2D): measured over the ridge (mesial and distal of the implant) when the crown can be removed.
- Evaluation of the biotype of peri-implant tissue (Rouk et al. 2009): thin or thick, according to the visualization of the periodontal probe through the peri-implant tissue.
Screw-retained implant crowns will be removed to observe clinical records, while cemented crowns will not be removed.
Radiographic measurements As a way of evaluating the stability of bone tissue, the interproximal level of the bone crest will be measured by means of periapical radiographs. After the radiographic takes, the radiographs will be scanned and the distance in millimeters from the interproximal bone crest to the base of the implant will be evaluated.
ISQ Stability Type 16 smartpegs will be inserted directly into the implants for ISQ evaluation Implant Stability Quotient) by means of an appropriate device (Osstell, Integration Diagnostics, Savadal, Sweden). For each series of measurements, the resonance analysis frequency unit (RFA - Resonance Frequency Analysis) will be used, observing that the ISQ varies between 1 and 100, and the measurements will be made 3 consecutive times to obtain the average.
3.4. Analysis Model
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values. The radiographic parameter will be calculated for each face (mesial and distal) and then the average among the volunteers in each evaluation period will be calculated separately. The Wilcoxon Rank non-parametric paired test will be used to compare differences between baseline values and each assessment period. The significance level will be 5%.
- Conditions
- Periodontitis, Periodontal Disease
- Being tested
- bone loss
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone lossDiagnostic test
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values (measured in mm)
Bone loss measured from the abutment-implant junction to the first visible bone to implant contact visible in a X-ray
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start28 Jun 2026 (estimated)
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guarulhos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamil awad shibli, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688408
- Sponsor's protocol ID
- 95602126.9.0000.5506
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Implants (7 and 8 mm) in Unitary Implant-supported Rehabilitations in the Posterior Sector of the Maxilla and Mandible: 5 Years of Follow-up
- ClinicalTrials.gov ID
- NCT07688408
- Acronym / sponsor ID
- 95602126.9.0000.5506
- Conditions
- Periodontitis, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GuarulhosUniversity, hospital or other
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Jul 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.
Implant-supported rehabilitation of regions with severe bone resorption is a challenge for implant dentists. Structures such as the maxillary sinus and the inferior alveolar canal often make it impossible to use implants of lengths considered standard in the literature. The use of short 7 and 8 mm implants with new macrogeometries and surface treatments, in addition to the application of Morse taper prosthetic connections, has shown results that increasingly encourage their use. However, the longevity of these rehabilitations needs to be constantly evaluated. In this work, unitary implant-supported rehabilitations in the posterior jaws, supported by short (7 and 8 mm) tapered Morse connection implants, will be followed for a period of 5 years. A total of 100 subjects rehabilitated with tapered Morse connection implants, with diameters between 3.5 and 4.5 mm, will be evaluated. Peri-implant bone remodeling, implant stability measured through ISQ and clinical parameters will be evaluated per implant and over the evaluation time. Periapical radiographs will be obtained and digitized, analyzed by software and compared with the initial data. The data obtained will be analyzed, allowing longitudinal evaluations and the success rate of implant restorations supported by short implants.
Detailed description
3.3. Clinical examinations A single, trained and calibrated examiner will perform all clinical examinations. The examiner will be trained and calibrated before and during the study in order to achieve maximum reproducibility in measurements. The methodology to be used for intra-examiner calibration will be the one recommended by Araujo et al. 2003, in which the standard error of measurement for continuous periodontal clinical parameters (SP and CIN) is evaluated. For the other clinical variables, the mean level of agreement between the examiners will be determined and considered satisfactory when the value is greater than 90% (Kappa test).
Clinical measures
The following parameters will be recorded at six sites per implant using a periodontal probe North Carolina (Hu-Friedy, Chicago, IL, USA):
- Plate index (PI): 0 = absence of plaque; 1 = separate patches of plaque at the cervical margin; 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; 3 = strip of plaque greater than 1 mm, but covering less than 1/3 of the tooth crown; 4 = plaque that covers at least 1/3 but less than 2/3 of the tooth's crown; 5 = plate covering 2/3 or more of the tooth's crown).
- Gingival index (GI): 0 = absence of inflammation; 1 = mild inflammation change in color and little change in texture; 2 = moderate inflammation - tempered glasses, redness, edema and hypertrophy; 3 = severe inflammation - marked redness and hyperplasia.
- Bleeding on probing (SS): 0 = absence; 1 = presence.
- Suppuration (Sup): 0 = absence; 1 = presence.
- Probing depth (PS): distance (mm) from the peri-implant mucosal margin to the most apical portion of the peri-implant pocket.
- Relative attachment level (NI): distance (mm) from the implant shoulder to the most apical portion of the peri-implant pocket.
- Keratinized tissue height (THA): vertical distance (mm) measured from the mucogingival line to the peri-implant margin in the center of the buccal face of the implant.
- Keratinized tissue thickness 1 (ETQ1): measured in the center of the buccal surface of the ridge, at the midpoint between the mucogingival line and the top of the ridge.
- Mesial and distal keratinized tissue thickness 2 (ETQ2M, ETQ2D): measured over the ridge (mesial and distal of the implant) when the crown can be removed.
- Evaluation of the biotype of peri-implant tissue (Rouk et al. 2009): thin or thick, according to the visualization of the periodontal probe through the peri-implant tissue.
Screw-retained implant crowns will be removed to observe clinical records, while cemented crowns will not be removed.
Radiographic measurements As a way of evaluating the stability of bone tissue, the interproximal level of the bone crest will be measured by means of periapical radiographs. After the radiographic takes, the radiographs will be scanned and the distance in millimeters from the interproximal bone crest to the base of the implant will be evaluated.
ISQ Stability Type 16 smartpegs will be inserted directly into the implants for ISQ evaluation Implant Stability Quotient) by means of an appropriate device (Osstell, Integration Diagnostics, Savadal, Sweden). For each series of measurements, the resonance analysis frequency unit (RFA - Resonance Frequency Analysis) will be used, observing that the ISQ varies between 1 and 100, and the measurements will be made 3 consecutive times to obtain the average.
3.4. Analysis Model
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values. The radiographic parameter will be calculated for each face (mesial and distal) and then the average among the volunteers in each evaluation period will be calculated separately. The Wilcoxon Rank non-parametric paired test will be used to compare differences between baseline values and each assessment period. The significance level will be 5%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals (> 21 years old), of both sexes, specifically rehabilitated with morse connection implants (Implacil De Bortoli, São Paulo, SP, Brazil) in the posterior region of the jaws for single-sided unsupported restorations, will be included in this study. Individuals will also need to have at least initial radiographic controls (immediately after implant placement) and 12 and 60 months of follow-up after implant placement. Individuals will be included in the population sample, with the following criteria observed: location, implant installation region, implant diameter, and adaptation.
Key inclusion criteria (1 listed)
- Individuals (> 21 years old), of both sexes, specifically rehabilitated with morse connection implants (Implacil De Bortoli, São Paulo, SP, Brazil) in the posterior region of the jaws for single-sided unsupported restorations, will be included in this study. Individuals will also need to have at least initial radiographic controls (immediately after implant placement) and 12 and 60 months of follow-up after implant placement. Individuals will be included in the population sample, with the following criteria observed: location, implant installation region, implant diameter, and adaptation.
Key exclusion criteria (1 listed)
- Immediate implants will be excluded, individuals with clinical records who, throughout the study, do not have radiographs for evaluation and/or radiographs of poor quality that make radiographic measurements impossible; medical records with insufficient data, filled out inappropriately or that indicate doubt about the details of the procedure performed.
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 |
|---|---|---|
| bone lossThe primary outcome variable of the study will be variation in bone remodeling between the initial and final values. | Diagnostic test | – |
Primary outcome
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values (measured in mm)
Time frame: 60 months
Bone loss measured from the abutment-implant junction to the first visible bone to implant contact visible in a X-ray
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 8 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontal Disease, run by University of Guarulhos at 1 site in Brazil.
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: opening soon, as of the sponsor's last update on 8 Jul 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 Brazil. 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?
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?
The primary outcome variable of the study will be variation in bone remodeling between the initial and final values (measured in mm) (time frame: 60 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 8 Jul 2026.