Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique

NCT03882216 | Unknown DMC

• 1 other identifier: 5111987
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will be formed on two groups : the control group and the test group For both groups base line impressions will be taken before the surgery and a free gingival graft will be harvested from the palate and deepithelialized to obtain the free connective tissue graft then In the control group: the free connective tissue graft will be inserted through crestal pouch previously prepared using split thickness flap. In the test group The free connective tissue graft will be slided through apical vertical incision in the pontic area previously tunneled. Post operative casts will be obtained by taking impressions after three months and six months to evaluate the volumetric changes in the pontic area.

Conditions

Ridge Deficency; Soft Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

• volumetric changes at the pontic site

  To evaluate the volumetric changes between the baseline and 6 months postoperatively all the cast stone models will be digitized using lab based optical scannerDigital cast models will be reproduced resembling different time points during treatmentSuperimposing the different models of the same case using the best fit algorithm by taking the tooth surfaces as references The area of pontic site will be defined by the mesial and distal papillary midline, the mucogingival line, and the alveolar crest So any volumetric changes between digitalized superimposed casts can be measured.

  6 months

Secondary Outcomes (1)

• Postoperative pain - through Visual Analogue Scale

  14 days

Study Arms (2)

test group pouch technique

EXPERIMENTAL

free connective tissue graft augmentation using pouch technique

Procedure: soft tissue augmentation using pouch technique

test group modified pouch technique

EXPERIMENTAL

free connective tissue graft augmentation using modified pouch technique

Procedure: soft tissue augmentation using modified pouch technique

Interventions

soft tissue augmentation using pouch technique PROCEDURE

crestal incision with split thickness flap without vertical releasing incision till the mucogingival line then apply the harvested connective tissue graft through it.

test group pouch technique

soft tissue augmentation using modified pouch technique PROCEDURE

tunneling will be done at the pontic site till the mucogingival line then a distant vertical incision near the tunnel at the lining mucosa where the harvested connective tissue graft wll be applied .

test group modified pouch technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Missing single tooth loss in anterior and premolar region.
• Seibert Class I ridge defect.
• Systemically free patients.
• The healing period after the tooth extraction had to be at least 3 months prior to the surgical procedures.

You may not qualify if:

• Smokers
• Occlusal trauma at site of graft
• Pregnancy and lactation
• Severe gagging reflex

Sponsors & Collaborators

• Cairo University: lead

Study Design

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

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 20, 2019
• Study Start: June 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 20, 2019

Record last verified: 2019-03