Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation

Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04559802

Enrollment

Registered

2020-09-23

Start date

2020-10-02

Completion date

2024-02-15

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

Brief summary

It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

Detailed description

Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.

Interventions

PROCEDURETransmucosal Technique

Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).

PROCEDURESubmerged Technique

Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age more than 21 years - ASA I or II. * Patient's willingness to participate in this study. * Availability for 4-month follow-up. * Absence of active periodontal disease. * Single tooth replacement is needed with simultaneous contour augmentation. * Available pre-operative CBCT study. * Extraction of tooth at least 8 weeks prior to planned implant therapy.

Exclusion criteria

* Pregnancy at the screening visit. * Smoking more than 10 cig/day. * Active infection at the site of surgery (teeth involved). * Multiple missing teeth adjacent to each other (long span edentulous area). * Vertical bone defect less than 2mm (intra surgical assessment)

Design outcomes

Primary

Measure	Time frame	Description
Hard tissue healing around dental implants	4 months	bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated.

Secondary

Measure	Time frame	Description
Soft tissue healing around dental implants	4 months	Soft tissue healing around Submerged and Non-submerged dental implants. Fisher's exact test will be used to evaluate soft tissue healing changes through analyzing the measurements obtained by periodontal probe and radiographs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026