Clinical trial NCT04984031: Apoptosis Markers in Aggressive Periodontitis
Official title: Assessment of Apoptosis Markers Caspase-3, Caspase-8, Caspase-9 and Apoptosis Inducing Factor (AIF) Levels in Generalized Versus Molar-incisor Grade C Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis)
Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study will carry out on fifty patients ranged in age from (18 - 75) years diagnosed as having aggressive periodontitis. All patients were selected from those attending at outpatient dental clinic of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology Department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Clinical and radiographic examination will be performed by two calibrated periodontists to confirm accurate diagnosis.

Brief summary: The aim of the present trial is to assess the gingival crevicular fluid level of caspase-3 and apoptosis inducing factor (AIF) in Generalized versus Molar-incisor grade C periodontitis.

The present study will be carried out on patients selected from those attending on the outpatient clinics of Department of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology, Faculty of Dental Medicine, Al-Azhar University, Assiut.

Detailed description: Periodontal diseases are inflammatory disorders that give rise to tissue damage and loss, as a result of complex interactions between pathogenic bacteria and host immune response. Gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss.(1,2) periodontitis, a disease characterized by gingival inflammation combined with connective tissue attachment and bone loss.

Aggressive periodontitis is a form of periodontal disease characterized by rapid attachment loss, bone destruction, non-contributory medical history and family history of the cases Apoptosis is a fundamental and complex biological process that enables an organism to kill and remove unwanted cells during development, normal homeostasis and disease.

Caspases are proteins implicated in the activation and execution of apoptosis was identified in humans as being crucial for this process. Caspases 3 appear to be activated in a protease cascade that leads to inappropriate activation or rapid disablement of key structural proteins and important signaling, homeostatic and repair enzymes and is essential for some of the characteristic changes in cell morphology and certain biochemical events associated with the execution and completion of apoptosis. However, the specific requirements of this caspase in apoptosis were until now largely unknown. Apoptosis-inducing factor (AIF) is a mitochondrion-localized flavoprotein with nicotinamide dinucleotide (NADH) oxidase activity is encoded by a nuclear gene. It has been shown to translocate from mitochondria to the cytosol as well as the nucleus when apoptosis is induced and mediate caspase-independent death because inhibition of caspase activation.

Many authors view apoptosis as a process that is near-to-synonymous to massive caspase activation. The existence of a caspase-independent death effector thus does not fit the dominant scheme. During the last 2 years, several papers advocated the hypothesis that AIF is indeed a caspase-dependent death effector, meaning that the translocation of AIF from the mitochondrion (where it would be inert) to the nucleus (where it would induce apoptosis) would be caspase-dependent.

Eligibility criteria: inclusion criteria

1. Patients must be free from any systemic diseases according to criteria of Modified Cornell Medical Index.
2. Males and females aged ≥18 years old.
3. All subjects should be cooperative.

exclusion criteria

1. females, who were lactating or pregnant, will be excluded.
2. smoker's or former smokers also will be excluded .
3. any other periodontal diseases, except generalized grade c periodontitis or molar-incisor grade c periodontitis
4. Patients received antibiotics or non- steroidal anti-inflammatory drugs 3 months or periodontal treatment 6 months' before the beginning of the study

Primary outcomes:
measure: caspase 3 , picograms/millimeter (pg/ml) in gingival crevicular fluid
timeFrame: through diagnosis completion, an average of 6 months
measure: caspase 8 , picograms/millimeter (pg/ml) in gingival crevicular fluid
timeFrame: through diagnosis completion, an average of 6 months
measure: caspase 9 , picograms/millimeter (pg/ml) in gingival crevicular fluid
timeFrame: through diagnosis completion, an average of 6 months
measure: Apoptosis Inducing Factor(AIF), picograms/millimeter (pg/ml) in gingival crevicular fluid
timeFrame: through diagnosis completion, an average of 6 months
Secondary outcomes:
measure: Gingival Index
timeFrame: through diagnosis completion, an average of 6 months
measure: Plaque Index
timeFrame: through diagnosis completion, an average of 6 months
measure: Attachment level
timeFrame: baseline, immediately after complete diagnosis and before any intervention or therapy
measure: Bleeding on probing (BOP)
timeFrame: through diagnosis completion, an average of 6 months
measure: radiographic evaluation at molar-incisor area
timeFrame: through diagnosis completion, an average of 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of dental medicine Al-Azhar University (Assiut branch)
state: Asyut
Study officials:
affiliation: Faculty of dental medicine Al-Azhar university Assiut Branch
name: Mohammed F Edress, associate professor
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial Pathology Department, Faculty of dentistry, Assiut University
name: Ahmed M Hussein, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of oral pathology Faculty of dental medicine Al-Azhar University (Assiut branch)
name: Ahmed H Gaber, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamonal J, Bascones A, Acevedo A, Blanco E, Silva A. Apoptosis in chronic adult periodontitis analyzed by in situ DNA breaks, electron microscopy, and immunohistochemistry. J Periodontol. 2001 Apr;72(4):517-25. doi: 10.1902/jop.2001.72.4.517.
citation: Dabiri D, Halubai S, Layher M, Klausner C, Makhoul H, Lin GH, Eckert G, Abuhussein H, Kamarajan P, Kapila Y. The Role of Apoptotic Factors in Assessing Progression of Periodontal Disease. Int J Dent Oral Sci. 2016 Sep;3(9):318-325. doi: 10.19070/2377-8075-1600064. Epub 2016 Sep 3.
citation: Armitage GC, Cullinan MP. Comparison of the clinical features of chronic and aggressive periodontitis. Periodontol 2000. 2010 Jun;53:12-27. doi: 10.1111/j.1600-0757.2010.00353.x.
citation: Nicholson DW, Thornberry NA. Caspases: killer proteases. Trends Biochem Sci. 1997 Aug;22(8):299-306. doi: 10.1016/s0968-0004(97)01085-2.