Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.

Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.

Lateral Epicondylitis

Tendoncel

Placebo control gel

Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou

An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis

A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy & Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis

15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.

30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).

Measured by participant questionnaire. Comparison of the number of participants in each group with cutaneous events - "redness", "rash", "swelling" or changes at gel site. Classed as none, mild, moderate or severe. Plus any other event mentioned by the participants.

Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.

Measurement of blood IgE levels. Comparison of the number of participants in each group, test and control, with a normal baseline reading of blood IgE and a subsequently elevated IgE reading. Normal is <100IU/mL.

Cell Therapy Ltd.

George Papanicolaou Hospital

Group A subjects will be given standard oral hygiene instructions on the visit with a standard 0.8 % metronidazole gel instructed to apply topically on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Subjects will be provided biweekly reminder via SMS in the form of text message reinforcing oral hygiene. Additionally, patients will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Group C will be subjects will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Gingivitis

The application of metronidazole gel is effective in the management of gingivitis in patients undergoing orthodontic therapy. Additionally, the constant reminder therapy at weekly interval would also lead to improvement in the oral hygiene.16 According to pertinent literature survey, none of the study has been conducted to compare the effectiveness of SMS reminders and use of anaerobic gel to reduce gingival inflammation.

Metronidazole gel

Subjects will be provided biweekly reminder via 'SMS text reminder' in the form of text message reinforcing oral hygiene. Additionally, patients will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

SMS text reminder

Placebo gel

Aga Khan University Hospital

Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients

Effectiveness of Metronidazole Gel and Mobile Telephone Short- Message Service Reminders on Gingivitis in Orthodontic Patients: A Randomized Controlled Trial

Improvement in Bleeding Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites. The study sites will be six proximal-buccal line angles on the following teeth: right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distolabial line angle; right mandibular central incisor, distolabial line angle; left mandibular canine, distobuccal line angle; and left mandibular second premolar, mesiobuccal line angle. If a study tooth was missing, the corresponding tooth on the contralateral side will be examined.
0. Absence of bleeding after 30 seconds
Bleeding observed after 30 seconds
Immediate bleeding

Improvement in Gingival Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites (same as above).
0. No inflammation.
Mild inflammation, slight change in color, slight edema, no bleeding on probing.
Moderate inflammation, moderate glazing, redness, bleeding on probing.
Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding

Improvement in Orthodontic Plaque Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites (same as above) and the condition of adjacent marginal gingiva by staining the teeth with plaque disclosing solution will be assessed.
0. No plaque deposits on the tooth surfaces surrounding the bracket base
Plaque deposits on one tooth surface at the bracket base
Plaque deposits on two tooth surface at the bracket base
Plaque deposits on three tooth surface at the bracket base
Plaque deposits on four tooth surface at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)

Hafiz Taha Mahmood

Principal Investigator

Aga Khan University

stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months

stratified equally to placebo taken once daily for 24 months

stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months

Placebo

stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months

Doxycycline Monohydrate

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months

Change in Dark Adaptation, Rod Intercept

Change in photopic visual fields between baseline and 24 months

Change in Photopic Visual Field

Change in Frequency Doubling Perimetry (FDP) from baseline, shown as mean and foveal (center of retina) scores

Change in Frequency Doubling Perimetry (FDP)

Change in ETDRS visual acuity letter score from baseline. ETDRS is measured on a scale of 0 to 70 where 0 means inability to see anything on the chart and 70 is normal (20/20) acuity.

Change in Early Treatment Diabetic Retinopathy Study (ETDRS)

Change in central subfield thickness from baseline

Change in Central Subfield Thickness

Change in Macular Volume

Change in Central Retinal Artery Equivalent (CRAE) diameter from baseline

Change in Central Retinal Artery Equivalent (CRAE) Diameter

Change in Central Retinal Vein Equivalent (CRVE) diameter from baseline

Change in Central Retinal Vein Equivalent (CRVE) Diameter

Change in arteriovenous ratio diameter from baseline

Change in Arteriovenous Ratio Diameter

Overall Study

Dr. Thomas W. Gardner

Diabetic Retinopathy

doxycycline monohydrate

placebo

Penn State University, Milton S. Hershey Medical Center

Penn State Hershey Eye Center, Department of Ophthalmology

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy

Evaluation of Effect of Doxycycline Verses Placebo on Diabetic Retinopathy Progression and Retinal Function in Patients With Severe Non-proliferative or Mild or Moderate (Non-high-risk) Proliferative Diabetic Retinopathy

cellulose/atrofia

An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis

Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients

Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy

CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography

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