Aggressive Periodontitis, GeneralizedNCT06970691
is Generalized Aggressive Periodontitis an Endless Disease When Does it Stop
An observational study of Aggressive Periodontitis, Generalized, run by Rasha Wagih at 1 site in Egypt.
Trial summary
Background: Inquiring thoroughly and systematically for evidence supporting the mechanism, time span, onset, or ending events of generalized aggressive periodontitis. The aim of the current retrospective cross-sectional study was to set temporal boundaries of the generalized form of aggressive periodontitis based on… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Aggressive Periodontitis, Generalized
- What is being tested?
- panoramic radiograph
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2020to 20 Dec 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: All radiographic panoramic records of patients, who were previously clinically diagnosed as generalized aggressive periodontitis, were included. Fills with other radiographic records other than panoramic views were excluded. For this study, the enrolled patients' age was selected ≥ 18 years of both genders. Radiographic evidence of bony defects was compulsory for inclusion.
Who may be able to join
- patients with generalized ggressive perioodntitis only
- Panoramic view is a must
- Patient age ≥ 18 years
- both genders were enrolled
- Radiographic evidence of bony defects was compulsory for inclusion.
Who cannot join
- patients who did not have panoramic radiograph in their files
- Patients less than 18 years are not included
Trial locations and contacts
1 site in 1 country.
About this study
Background: Inquiring thoroughly and systematically for evidence supporting the mechanism, time span, onset, or ending events of generalized aggressive periodontitis. The aim of the current retrospective cross-sectional study was to set temporal boundaries of the generalized form of aggressive periodontitis based on eruption time of permanent teeth via panoramic radiographs.
Methods: based on the Egyptian chronology, the primary outcome of the current retrospective study was to assess the correlation between the eruption sequence and the temporal borders of the disease as well as the prevalence of destructive events in accordance to the eruption schedule. The first affected tooth, the last affected tooth, the first unaffected tooth, the number of affected teeth, the presence of interrupted tooth all are factors that extracted from the panoramic radiographs.
Read the detailed description
During the last decades, progressive lines of thinking were proposed by generations of brilliant periodontists who tried to describe the aggressive destruction of periodontal tissues. Periodontitis was basically described 2000 years ago but in 18th century, signs and symptoms of periodontitis were firstly recorded.
History of aggressive periodontitis At the beginning of 19th century, alveolar pyorrhea was a term created and explained by two different schools; the European school has described it as a disease which is not affected by local factors while the American school has described local factors especially salivary calculus as the main cause behind alveolar pyorrhea.
Later by the development of histological, radio graphical and microbiological analysis, three other explanation were raised; school of atrophy and degeneration, school of occlusal trauma and school of infection. The European School has supported the theory of atrophy and degeneration especially in young individuals. Their explanation was mainly based on the histological studies which concluded that alveolar bone loss is the primary crucial point in periodontal disease preceded by gingival ulceration and inflammation. Pocket formation and epithelial proliferation are secondary events. Furthermore, they also reported that inflammation and suppuration are strongly connected to the presence of external irritation and entitled it ''Diffuse atrophy''.
Classification of Aggressive periodontitis In 80s and 90s, numerous classifications with various staging and subtypes had been conducted which were not based upon the true diagnostic background. In 1986, the American academy of periodontology acknowledged the exclusion of rapidly progressive periodontitis and added prepubertal periodontitis as a subclass to juvenile periodontitis. In 1989, the American academy classification was modified. They proposed early onset periodontitis to include both prepubertal, juvenile and rapidly progressive periodontitis and added periodontitis associated with systemic disease as separate entity. In 1989, Topic subdivided the periodontal conditions into acute and chronic. The acute condition included periodontal abscess, pericoronitis while the chronic condition included periodontitis (simplex, complex and generalized forms), localized forms (juvenile, post-juvenile and prepubertal) and symptomatic. The latter classification was lacking essential details concerning the periodontal diseases. In 1994, the European Workshop on Periodontology condensed the previous classes into; early onset, adult and necrotizing periodontitis. In 1997, the Committee of American Academy of Periodontology had set a plan to revise the previously proposed classifications.
Sub-typing of aggressive periodontitis Early onset description of periodontitis was mainly based on the influence of patient's age at the time of reporting the evolution of symptoms added to the short-term period in which uppermost destructive events had happened. In 1989 classification, early onset periodontitis was sub-categorized as pre-pubertal juvenile and rapidly progressive periodontitis. Both sub-categories approved to be either localized or generalized.
In 1999, Armittage classification replaced the term ''Early onset periodontitis, EOP'' with ''Aggressive periodontitis''. The term Aggressive periodontitis described the early onset events that cause severe and rapid periodontal damage in young patients. Aggressive periodontitis was directly classified into localized; LJP (classical incisor-molar pattern) and generalized forms. Here, the ages as well as the time scale period of destruction were not determinant factors for the nature of the disease as in 1989 classification. It was mainly based on the degree and distribution of destruction. No difference was defined to differentiate primary or permanent teeth affection.
In 2018, the latest classification added the molar-incisor pattern (MIPP) as a separate subtype of severe periodontitis from the localized form. It affects only the incisors and molars.
Difference between Chronic and aggressive periodontitis According to 1999 classification, there were four main features that categorized aggressive over the chronic one. Firstly, the onset; where aggressive periodontitis begins its manifestation in a relatively young age. Secondly, the rate of destruction is more rapid in aggressive form. Thirdly, the familial background in aggressive is more prone to affect more than one person in the same family. Fine et al., 2018, in their latest classification, combined both diseases into only one category called ''Periodontitis'' and added a staging and grading system. The authors could not stand totally against the existence of aggressive periodontitis nature as a separate unique entity with the explicit, lesions' location, familial background, rate of progression, age of onset and the deposits amount. The combination of the 2 categories was explained due to the absence of enough solid evidence for aggressive periodontitis describing it as a separate entity.
Unfortunately, from the knowledge in the literature, aggressive periodontitis, as a disease, represents a gap of knowledge. The nature of the disease, the incidence of initiation, when it ends, if it is accompanied by other medical problems, and if it is a solitary manifestation of a rare independent disease that is not related to any other body organs, all are questions that couldn't find a clue.
Research hypothesis In the current research, we propose that generalized aggressive periodontitis, begins at or before the eruption of the first permanent tooth. Then, it continues without quiescence period (not interrupted) till it stops exactly when the immune system shows enough maturation. We speculated that the eruption time scale of the affected tooth translates disease activity during this period while eruption of unaffected permanent tooth indicates point time of disease suppression.
- Conditions
- Aggressive Periodontitis, Generalized
- Being tested
- panoramic radiograph
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panoramic radiographDiagnostic test
Panoramic radiographs for aggressive periodontitis previously diagnosed cases were interpreted by single examiner (NY). The included radiographs had to fulfill the following; 1) sufficient image quality; 2) All teeth with the surrounding alveolar bone had to be clear enough to facilitate alveolar bone tracing; 3) Only pre-operative radiographs were enrolled (before the surgical management of bony defects).
What is being measured
The primary outcome is the main question the study is designed to answer.
the radiographic eruption date of the first and the last affected teeth
based on panoramic view of each patient, the radiographic eruption date of the mentioned teeth was determined.
Measured: 4 years
Secondary outcomes (1)
The radiographic status of the supporting structures of third molars
based on the panormaic view of each patient, the condiiton of the surrounding structures of thord molar teeth was assessed (periodontally affected or not).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start16 Jan 2020
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Periodontitis, GeneralizedStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rasha Wagih
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasha Wagih, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970691
- Sponsor's protocol ID
- 240418-89
- Status last verified
- May 2025
- First submitted
- 17 Mar 2025
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- is Generalized Aggressive Periodontitis an Endless Disease When Does it Stop
- ClinicalTrials.gov ID
- NCT06970691
- Acronym / sponsor ID
- 240418-89
- Conditions
- Aggressive Periodontitis, Generalized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rasha WagihUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 14 May 2025 (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: Inquiring thoroughly and systematically for evidence supporting the mechanism, time span, onset, or ending events of generalized aggressive periodontitis. The aim of the current retrospective cross-sectional study was to set temporal boundaries of the generalized form of aggressive periodontitis based on eruption time of permanent teeth via panoramic radiographs.
Methods: based on the Egyptian chronology, the primary outcome of the current retrospective study was to assess the correlation between the eruption sequence and the temporal borders of the disease as well as the prevalence of destructive events in accordance to the eruption schedule. The first affected tooth, the last affected tooth, the first unaffected tooth, the number of affected teeth, the presence of interrupted tooth all are factors that extracted from the panoramic radiographs.
Detailed description
During the last decades, progressive lines of thinking were proposed by generations of brilliant periodontists who tried to describe the aggressive destruction of periodontal tissues. Periodontitis was basically described 2000 years ago but in 18th century, signs and symptoms of periodontitis were firstly recorded.
History of aggressive periodontitis At the beginning of 19th century, alveolar pyorrhea was a term created and explained by two different schools; the European school has described it as a disease which is not affected by local factors while the American school has described local factors especially salivary calculus as the main cause behind alveolar pyorrhea.
Later by the development of histological, radio graphical and microbiological analysis, three other explanation were raised; school of atrophy and degeneration, school of occlusal trauma and school of infection. The European School has supported the theory of atrophy and degeneration especially in young individuals. Their explanation was mainly based on the histological studies which concluded that alveolar bone loss is the primary crucial point in periodontal disease preceded by gingival ulceration and inflammation. Pocket formation and epithelial proliferation are secondary events. Furthermore, they also reported that inflammation and suppuration are strongly connected to the presence of external irritation and entitled it ''Diffuse atrophy''.
Classification of Aggressive periodontitis In 80s and 90s, numerous classifications with various staging and subtypes had been conducted which were not based upon the true diagnostic background. In 1986, the American academy of periodontology acknowledged the exclusion of rapidly progressive periodontitis and added prepubertal periodontitis as a subclass to juvenile periodontitis. In 1989, the American academy classification was modified. They proposed early onset periodontitis to include both prepubertal, juvenile and rapidly progressive periodontitis and added periodontitis associated with systemic disease as separate entity. In 1989, Topic subdivided the periodontal conditions into acute and chronic. The acute condition included periodontal abscess, pericoronitis while the chronic condition included periodontitis (simplex, complex and generalized forms), localized forms (juvenile, post-juvenile and prepubertal) and symptomatic. The latter classification was lacking essential details concerning the periodontal diseases. In 1994, the European Workshop on Periodontology condensed the previous classes into; early onset, adult and necrotizing periodontitis. In 1997, the Committee of American Academy of Periodontology had set a plan to revise the previously proposed classifications.
Sub-typing of aggressive periodontitis Early onset description of periodontitis was mainly based on the influence of patient's age at the time of reporting the evolution of symptoms added to the short-term period in which uppermost destructive events had happened. In 1989 classification, early onset periodontitis was sub-categorized as pre-pubertal juvenile and rapidly progressive periodontitis. Both sub-categories approved to be either localized or generalized.
In 1999, Armittage classification replaced the term ''Early onset periodontitis, EOP'' with ''Aggressive periodontitis''. The term Aggressive periodontitis described the early onset events that cause severe and rapid periodontal damage in young patients. Aggressive periodontitis was directly classified into localized; LJP (classical incisor-molar pattern) and generalized forms. Here, the ages as well as the time scale period of destruction were not determinant factors for the nature of the disease as in 1989 classification. It was mainly based on the degree and distribution of destruction. No difference was defined to differentiate primary or permanent teeth affection.
In 2018, the latest classification added the molar-incisor pattern (MIPP) as a separate subtype of severe periodontitis from the localized form. It affects only the incisors and molars.
Difference between Chronic and aggressive periodontitis According to 1999 classification, there were four main features that categorized aggressive over the chronic one. Firstly, the onset; where aggressive periodontitis begins its manifestation in a relatively young age. Secondly, the rate of destruction is more rapid in aggressive form. Thirdly, the familial background in aggressive is more prone to affect more than one person in the same family. Fine et al., 2018, in their latest classification, combined both diseases into only one category called ''Periodontitis'' and added a staging and grading system. The authors could not stand totally against the existence of aggressive periodontitis nature as a separate unique entity with the explicit, lesions' location, familial background, rate of progression, age of onset and the deposits amount. The combination of the 2 categories was explained due to the absence of enough solid evidence for aggressive periodontitis describing it as a separate entity.
Unfortunately, from the knowledge in the literature, aggressive periodontitis, as a disease, represents a gap of knowledge. The nature of the disease, the incidence of initiation, when it ends, if it is accompanied by other medical problems, and if it is a solitary manifestation of a rare independent disease that is not related to any other body organs, all are questions that couldn't find a clue.
Research hypothesis In the current research, we propose that generalized aggressive periodontitis, begins at or before the eruption of the first permanent tooth. Then, it continues without quiescence period (not interrupted) till it stops exactly when the immune system shows enough maturation. We speculated that the eruption time scale of the affected tooth translates disease activity during this period while eruption of unaffected permanent tooth indicates point time of disease suppression.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All radiographic panoramic records of patients, who were previously clinically diagnosed as generalized aggressive periodontitis, were included. Fills with other radiographic records other than panoramic views were excluded. For this study, the enrolled patients' age was selected ≥ 18 years of both genders. Radiographic evidence of bony defects was compulsory for inclusion.
Key inclusion criteria (5 listed)
- patients with generalized ggressive perioodntitis only
- Panoramic view is a must
- Patient age ≥ 18 years
- both genders were enrolled
- Radiographic evidence of bony defects was compulsory for inclusion.
Key exclusion criteria (2 listed)
- patients who did not have panoramic radiograph in their files
- Patients less than 18 years are not included
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 |
|---|---|---|
| panoramic radiographPanoramic radiographs for aggressive periodontitis previously diagnosed cases were interpreted by single examiner (NY). The included radiographs had to fulfill the following; 1) sufficient image quality; 2) All teeth with the surrounding alveolar bone had to be clear enough to facilitate alveolar bone tracing; 3) Only pre-operative radiographs were enrolled (before the surgical management of bony defects). | Diagnostic test | – |
Primary outcome
the radiographic eruption date of the first and the last affected teeth
Time frame: 4 years
based on panoramic view of each patient, the radiographic eruption date of the mentioned teeth was determined.
1 secondary outcome
The radiographic status of the supporting structures of third molars
Time frame: 4 years
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 14 May 2025.
- Individual participant dataSharing planned: No
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.
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 Aggressive Periodontitis, Generalized, run by Rasha Wagih 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 2 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 14 May 2025. 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?
the radiographic eruption date of the first and the last affected teeth (time frame: 4 years). 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 14 May 2025.