Dental Implants Clinical Trial
Official title:
Evaluation of Dental Implant Treatment With and Without Flap for Clinical, Radiographic and Patient Comfort
Verified date | July 2020 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this clinical study is to compare two different approaches during dental implant
applications. One group of patients in the study received flapless approach which is
performed without surgical reflection of soft tissues (gums) during implant surgery. In the
control group of the study, patients received conventional flap approach in which flap
reflections performed on soft tissues (gums) of the patients.
After the surgery patients were monitored for marginal bone loss around implants and
discomfort after the surgery for 3 months. And received data statistically analyzed to
compare the different surgical procedures.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 12, 2020 |
Est. primary completion date | June 12, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Systemically healthy (The determination of healthy volunteers will be based on the patient's statements in the anamnesis received. Additional examinations will not be performed.) - Not smoking, - Does not have a medication that he constantly uses, - who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months, - Patients who are not in pregnancy, lactation, menstruation or menopause, - Patients with at least 1 tooth deficiency, - Patients who accepted the research and signed the informed volunteer consent form Exclusion Criteria: - Regularly using a systemic medication, - During pregnancy, lactation, menstruation or menopause, - Have any oral or systemic diseases, - Receiving antibiotic, anti-inflammatory or systemic corticosteroid drug treatment in the last 6 months, - Patients with no teeth deficiency |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Katip Celebi University Faculty of Dentistry | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University |
Turkey,
Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24. — View Citation
Becker W, Goldstein M, Becker BE, Sennerby L, Kois D, Hujoel P. Minimally invasive flapless implant placement: follow-up results from a multicenter study. J Periodontol. 2009 Feb;80(2):347-52. doi: 10.1902/jop.2009.080286 . — View Citation
Becker W, Goldstein M, Becker BE, Sennerby L. Minimally invasive flapless implant surgery: a prospective multicenter study. Clin Implant Dent Relat Res. 2005;7 Suppl 1:S21-7. — View Citation
Costich ER, Ramfjord SP. Healing after partial denudation of the alveolar process. J Periodontol. 1968 May;39(3):127-34. — View Citation
Rao W, Benzi R. Single mandibular first molar implants with flapless guided surgery and immediate function: preliminary clinical and radiographic results of a prospective study. J Prosthet Dent. 2007 Jun;97(6 Suppl):S3-S14. doi: 10.1016/S0022-3913(07)60003-1. Erratum in: J Prosthet Dent. 2008 Mar;99(3):167. — View Citation
Rocci A, Martignoni M, Gottlow J. Immediate loading in the maxilla using flapless surgery, implants placed in predetermined positions, and prefabricated provisional restorations: a retrospective 3-year clinical study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:29-36. — View Citation
Sclar AG. Guidelines for flapless surgery. J Oral Maxillofac Surg. 2007 Jul;65(7 Suppl 1):20-32. Review. Erratum in: J Oral Maxillofac Surg. 2008 Oct;66(10):2195-6. — View Citation
Staffileno H. Significant differences and advantages between the full thickness and split thickness flaps. J Periodontol. 1974 Jun;45(6):421-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early marginal bone loss around implant neck. | Bite wing x-rays taken with parallel technique for both groups were evaluated and recorded between the baseline and the 3rd month around the implant neck. | Immediately after implant placement - 3 months after surgery. | |
Secondary | Visual analog scale -Patient discomfort after surgery. | Patients were given questionnaire for assessment of discomfort after surgery. | Immediately after implant surgery - 3 days after surgery - 7 days after surgery . | |
Secondary | The Turkish translation of Oral Health Impact Profile (OHIP-14) forms - Patient discomfort after surgery. | Patients were given questionnaire for assessment of discomfort after surgery. | Immediately after implant surgery - 3 days after surgery - 7 days after surgery . |
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