Vertical interproximal periodontal defects in differing quadrants of the mouth Oral Health At least 2 vertical interproximal periodontal defects in differing quadrants of the mouth.
Conditions
Interventions
Participants who fulfil the entrance criteria of at least 2 vertical interproximal defects present in different quadrants in the mouth will be randomised using a split-mouth design to receive either t
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate and voluntary written informed consent 2. Aged 18 years or older 3. Willing, able and likely to comply with all study procedures and restrictions 4. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination 5. At least 2 vertical interproximal periodontal defects in different quadrants of the mouth as evidenced by radiographic investigation 6. Full mouth Turesky plaque index score <2 7. Non-smoker or have stopped smoking for ?6 months prior to surgery
Exclusion criteria
Exclusion criteria: 1. Pregnant or who are intending to become pregnant over the duration of the study 2. Breastfeeding 3. Current or recurrent disease/dental pathology that could affect the assessments 4. Bleeding disorders 5. Immuno-compromised 6. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study products or procedures. 7. Tooth with less than grade I mobility 8. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 9. Use of antibiotics one month prior to start of the study 10. Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit 11. Recent history of alcohol or other substance abuse 12. Member of the study site or a family relative. The study site for this protocol is the Clinical Trials Unit in the Bristol Dental Hospital. Employees of the Bristol Dental Hospital not associated with the Clinical Trials Unit are eligible to participate 13. Any participant who, in the judgement of the investigator, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether PRGF supports the predictable regeneration of the lost periodontal tissue by assessing clinical attachment levels using: 1. Bleeding on probing 2. Pocket depth (mm) 3. Gingival recession measured from the amelo-cemental junction (mm) 4. Clinical attachment level (gingival recession + pocket depth in mm) 5. Width of keratinized mucosa at the surgical site (mm) 6. Biotype of the gingiva (thin/thick) 7. Turesky plaque index (0-5) 8. Suppuration 9. Mobility - 0, I, II, III [13] 10. Furcation - 0, I, II, III [14] 11. Radiograph of each surgical site 12. Photograph of each surgical treatment site during surgery 12. Bony defect classification (1, 2, 3) (to be recorded once exposed) This will be completed at the baseline and 8-12 weeks following each surgery with the exception of outcome measure 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine whether the use of PRGF in periodontal regeneration surgery is more effective than a conventional surgical approach alone in improving clinical attachment loss by assessing clinical attachment levels, through the same method as per the primary outcome measure, at the baseline and 8-12 weeks following each surgery. | — |
Countries
England, United Kingdom
Outcome results
None listed