Soft Tissue Augmentation Clinical Trial
Official title:
Clinical Comparison of Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique: A Randomized Controlled Clinical Trial
Verified date | March 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will be formed on two groups : the control group and the test group For both groups
base line impressions will be taken before the surgery and a free gingival graft will be
harvested from the palate and deepithelialized to obtain the free connective tissue graft
then In the control group: the free connective tissue graft will be inserted through crestal
pouch previously prepared using split thickness flap.
In the test group The free connective tissue graft will be slided through apical vertical
incision in the pontic area previously tunneled.
Post operative casts will be obtained by taking impressions after three months and six months
to evaluate the volumetric changes in the pontic area.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Missing single tooth loss in anterior and premolar region. 2. Seibert Class I ridge defect. 3. Systemically free patients. 4. The healing period after the tooth extraction had to be at least 3 months prior to the surgical procedures. Exclusion Criteria: 1. Smokers 2. Occlusal trauma at site of graft 3. Pregnancy and lactation 4. Severe gagging reflex |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | volumetric changes at the pontic site | To evaluate the volumetric changes between the baseline and 6 months postoperatively all the cast stone models will be digitized using lab based optical scannerDigital cast models will be reproduced resembling different time points during treatmentSuperimposing the different models of the same case using the best fit algorithm by taking the tooth surfaces as references The area of pontic site will be defined by the mesial and distal papillary midline, the mucogingival line, and the alveolar crest So any volumetric changes between digitalized superimposed casts can be measured. | 6 months | |
Secondary | Postoperative pain - through Visual Analogue Scale | Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain) VAS will be recorded at day 14 | 14 days |
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