Instructions for Completing Form



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Periodontal Adverse Event Form (PAE)

Instructions for Completing Form



Participant Group: This form is completed for participants enrolled in the MOTOR study and diagnosed with a periodontal adverse event.
When completed: This form should be completed as soon as possible after discovery and diagnosis of a periodontal adverse event.
Who completes: Motor Dental Examiner or Therapist, and signed by Study Dentist
Other Documents: If the adverse event is defined as serious, complete Form SAE, Serious Adverse Event Form.
Form Instructions:
Header:

  • ID: Attach Participant ID label.

  • Name: Record the participants name (this is not data entered).

  • Vist: Record the visit number that corresponds to where the participant is in the study.

  • Seq: Seq # is 01, and enumerates with multiple IHF forms within a Visit Number

  • Staff ID: Record initials of staff collecting BDF data.

  • Date: Record date of LDF data collection

Special Instructions:



  • Complete this form upon discovering and diagnosing a periodontal adverse event at any time during the study.

  • If any of these conditions constitute serious adverse events, life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or in your opinion represent another significant hazard or potentially serious harm to the participant or others, a study dentist must verify the diagnosis, and an SAE form must be completed and reported per study procedures.

  • PAE data collection forms are to be entered into the MOTOR DMS within 1 week of detection.

  • Adverse Event Forms are to be updated monthly/regularly throughout the study to document the resolution of event.



Instructions on How to Complete Form Items:
Question 1. Periodontal Event Diagnosis:

Describe the periodontal adverse event diagnosis by checking all applicable diagnoses listed. If a diagnosis is not listed, check Item (e) and specify in the space provided.

A periodontal adverse event in MOTOR includes the following developments:


  • Periodontal or gingival abscess, a fluctuant (not firm) mass within the gingiva. Pus can usually be expressed from the lesion, either through the crevice, pocket, or sinus tract. The surface of the lesion is usually red and shiny. Symptoms may include throbbing, radiating pain, tenderness to touch, and tender and enlarged lymph nodes. Periodontal and gingival abscesses are distinguished from each other based on whether the lesion is localized to the gingival tissues (gingival abscess) or if it extends apically along the root surface (periodontal abscess). Gingival abscesses are more common in the maxillary tuberosity area distal to second or third molars. Care must be taken to distinguish a periodontal from a periapical abscess. Pulp vitality testing is the most reliable means of making this distinction. Swellings adjacent to non-vital teeth are likely periapical abscesses. Finally, it is possible that an abscess may be both periodontal and periapical in origin.




  • Pyogenic granuloma “pregnancy tumor”. A pregnancy tumor is a discrete, mushroom-like flattened mass that protrudes from the gingival margin or interproximal space. The surface is deep red and smooth. The lesion is usually painless but may become ulcerated and tender if it interferes with the participant’s bite. The tissue bleeds easily and is usually associated with some local irritants.




  • Pregnancy gingivitis. In pregnancy gingivitis, the marginal tissues are moderately to severely enlarged. The gingival are bright red or magenta, soft and friable, and have a smooth shiny surface. Moderate to profuse bleeding can occur spontaneously or with slight manipulation (e.g., mastication, during tooth brushing or flossing, or following gentle probing). While pregnancy does not cause gingivitis, it can exacerbate existing inflammation due to local irritants.




  • Progressive periodontal disease. Evidence of progressive clinical attachment loss is defined as an increase from baseline in clinical attachment loss greater than 3 mm. NOTE: In the absence of regular follow-up periodontal examinations, this information will be calculated by the DSCC when post natal examinations begin and included in regular DSMB reporting of periodontal adverse events.

A periodontal adverse event in MOTOR may also include other symptoms or complaints that are not described here, but suspected to be adverse.



Question 2. Are any of the above diagnoses considered to be a Serious Event?

If at least one of the diagnoses specified in Q1 is considered to be a Serious Event, then circle “Y”. An SAE form must be completed in this case.


A Serious Adverse Event is defined as any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or, in the opinion of the investigators, represents other significant hazards or potentially serious harm to research participants or others.

Question 3. Indicate treatments rendered.

Check the box before any treatment that was rendered for the periodontal adverse event, and enter the date of treatment in MM/DD/20YY format. If treatment was recommended but the participant refused it, check Item (a) and enter the date of refusal. If the treatment rendered is not listed, check Item (g) and specify in the space provided.



Question 4. Comments:

Circle “Y” if there are additional comments concerning this periodontal adverse event, and explain in the space provided. Attach additional pages if necessary.




PAE_QxQ / April 20, 2005 Page of


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