In the Treatment of Implants With Different Methods; Early Bone Loss and Patient Satisfaction

NCT04459494 | Completed

• 1 other identifier: 20164753772
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Dental Implants; marginal bone loss; flapless implant surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual analog scale -Patient discomfort after surgery.

  Immediately after implant surgery - 3 days after surgery - 7 days after surgery .

• The Turkish translation of Oral Health Impact Profile (OHIP-14) forms - Patient discomfort after surgery.

  Immediately after implant surgery - 3 days after surgery - 7 days after surgery .

Study Arms (2)

Test group

EXPERIMENTAL

Patients undergoing dental implant treatment without flap removal (Test Group)

Procedure: Flapless implant surgery.

Control group

ACTIVE COMPARATOR

Patients who will receive dental implants by removing conventional full thickness flaps (Control group)

Procedure: Conventional implant surgery.

Interventions

Flapless implant surgery. PROCEDURE

Local anesthesia will be applied to the patients in the test group, and then the implant socket will be prepared without removing the flap and a dental implant will be placed. Bite-wing film will be taken to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film.

Test group

Conventional implant surgery. PROCEDURE

Local anesthesia will be applied to the patients in the control group, and then the implant socket will be prepared after reflecting the flap and a dental implant will be placed. Patients in the control group will receive a full thickness flap elevation and an implant socket will be prepared afterwards the implant will be placed and then the flap will be closed with 4-0 silk suture. Bite-wing film will be taken from both groups to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Faculty of Dentistry

Izmir, 35000, Turkey (Türkiye)

Location

Related Publications (8)

• Sclar AG. Guidelines for flapless surgery. J Oral Maxillofac Surg. 2007 Jul;65(7 Suppl 1):20-32. doi: 10.1016/j.joms.2007.03.017.

  PMID: 17586346 BACKGROUND

• Costich ER, Ramfjord SP. Healing after partial denudation of the alveolar process. J Periodontol. 1968 May;39(3):127-34. doi: 10.1902/jop.1968.39.3.127. No abstract available.

  PMID: 5240004 BACKGROUND

• Staffileno H. Significant differences and advantages between the full thickness and split thickness flaps. J Periodontol. 1974 Jun;45(6):421-5. doi: 10.1902/jop.1974.45.6.421. No abstract available.

  PMID: 4525958 BACKGROUND

• 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. doi: 10.1111/j.1708-8208.2003.tb00013.x.

  PMID: 12691648 BACKGROUND

• 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. doi: 10.1111/j.1708-8208.2005.tb00071.x.

  PMID: 16137084 BACKGROUND

• 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.

  PMID: 17618931 BACKGROUND

• 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.

  PMID: 19186977 BACKGROUND

• 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.

  PMID: 20497439 BACKGROUND

Study Officials

• Şükrü ENHOŞ

  Izmir Katip Celebi University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dentist

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: October 15, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)