The Effect Of Vertical Releasing Incision On Implant Procedures

NCT06322901 | Completed

• 1 other identifier: TDH-2018-7883
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort.

Conditions

Bone Loss; Flap Design

Keywords

flap design; vertical incision; OPG-RANKL; cortisol

Outcome Measures

Primary Outcomes (1)

• Bone loss

  The degree of marginal bone loss (MBL) at the end of the 3rd month was determined and compared to the initial value. The following data were used to determine MBL: radiological marginal bone loss (RMBL), radiological implant length (RDİL), and real implant length (RİL).

  İnitial to 3rt mounth

Other Outcomes (3)

• OPG/RANKL

  days 3, 7, 14, 30, and 90

• visual analog scale (VAS)

  days 3, 7, and 14

• cortisol levels

  days 3, 7, 14, 30, and 90

Study Arms (2)

test side

EXPERIMENTAL

A mid-crestal incision was made on the test side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth and a 5-mm vertical incision was made disto-obliquely to the distal crestal incision

Procedure: Flap

control side

ACTIVE COMPARATOR

Only a mid-crestal incision was made on the control side with a no. 12 scalpel and a sulcular incision was made around the first natural tooth

Procedure: Flap

Interventions

Flap PROCEDURE

Different flap designs for implant placement

control side; test side

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bilateral tooth deficiency in the lower jaw posterior region who received 2 dental implants on the right and left sides were recruited from the Erciyes University Faculty of Dentistry Department of Periodontology between December 2018 and January 2020

You may not qualify if:

• Patients were excluded if they had any systemic disease, demonstrated bone structure unsuitable for a 3.7 × 10 mm dental implant, were pregnant, had previously received radiotherapy or chemotherapy, had a tooth extracted from the implant area within 6 months, had active periodontal disease, required antibiotic prophylaxis, had inadequate keratinized gingiva, or demonstrated a tissue phenotype \>2 mm.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry

Melikgazi, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Study Officials

• Duygu Kılıç, Dr

  Erciyes University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 21, 2024
• Study Start: August 5, 2018
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)