Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery

Not Applicable

• Conditions: Healing Surgical Wounds; Bone Loss

• Registration Number: NCT04195841
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed Description

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.

The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-12-31
• Status Verified: 2021-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-01
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Patients with single or multiple edentulous spaces in the maxillary and mandibular arches having Siebert's Class 1 and 2 ridge defects.
2. Patients willing to participate in the study.
3. Patients above 18 years of age.
4. Patients exhibiting keratinized tissue width more than or equal to 2 mm.
5. Systemically healthy patients.
6. Patients who demonstrate full mouth plaque control and bleeding scores<25% and showing good compliance.

Exclusion Criteria

1. Patients who do not give consent.
2. Untreated periodontal disease, caries.
3. Insufficient oral hygiene.
4. Smokers.
5. Previous radiation therapy.
6. Patients with known systemic diseases and conditions
7. Pregnant and lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inter proximal bone level	6 months	Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up
Healing	7 days	Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing.

Secondary Outcome Measures

Name	Time	Method
Visual Analouge Score	7 days	a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded.
Clinical attachment level	3 months	The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa

Trial Locations

Locations (1)

Krishnadevaraya college of dental sciences; 🇮🇳 Bangalore, Karnataka, India