Clinical trial NCT04195841: Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery
Official title: Influence of Z Shaped Incisions on Healing and Interproximal Bone Loss in Comparison With Conventional Sulcular Incisions (H Shaped) in Implant Surgery Under Magnification: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Healing Surgical Wounds
Keywords: implant incisions
bone loss
Z shaped incision
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were made one test and control. All the subjects required rehabilitation with implants.In the test group Z shaped incision was placed. in control group sulcular H shaped incision was placed.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inter proximal bone level
timeFrame: 6 months
measure: Healing
timeFrame: 7 days
Secondary outcomes:
measure: Visual Analouge Score
timeFrame: 7 days
measure: Clinical attachment level
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Rajiv Gandhi University of Health Sciences
name: Dr Shobith S Mampuzha, MDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajiv Gandhi University of Health Sciences
name: Dr Prabhuji MLV, MDS
role: PRINCIPAL_INVESTIGATOR
References: