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

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ClinicalTrials.gov Identifier: NCT03882216
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Hassan Abdle Aziz Ammar, Cairo University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ridge Deficency Soft Tissue Augmentation Procedure: soft tissue augmentation using pouch technique Procedure: soft tissue augmentation using modified pouch technique Not Applicable

Detailed Description:

Study settings: Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University Pre-surgical phase: Patients will be initially examined. All patients received oral hygiene instructions, and non-surgical periodontal treatment will be performed if necessary. At baseline, clinical periodontal measurements including plaque Index, bleeding on probing (BOP) , probing depth (PD) and clinical attachment level (CAL) will be recorded at teeth adjacent to the gap using a Williams's periodontal probe. Impressions will be taken using high viscosity impression material. Models will be cast in dental stone and used as the baseline reference for volumetric measurements. De-epithelialized connective tissue harvesting: The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques ). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection. The graft will then be de-epithelialized, and the connective tissue graft will be used. Surgical site preparation for either control or intervention group: 1- Local anesthesia (2% lidocaine, 1: 100 000 epinephrine), incisions will be placed over the crest of the ridge reaching to alveolar bone. 2- Papillae will include in the incision line only when there is a loss of papillary height. 3- A deep supraperiosteal soft tissue pouch will be prepared by sharp dissection extending apically to the mucogingival line and to the neighboring teeth mesio-distally. 4- A rectangular shaped free gingival graft will be harvested from the contralateral palate using split thickness dissection.

Control group: -The graft will be de-epithelialized and the connective tissue graft will be inserted into the pouch that will be previously prepared at the recipient site and will be secured with two non-resorbable sutures at the labial and the palatal aspect. - Provisional restoration will be temporary cemented. -. Patient will be recalled after 14 days for suture removal.

Test group: Modified pouch technique -. De-epithelialization of the area that resembles in position and size the emergence profile of the pontic -. Tunnel preparation in the soft tissues buccal to the defect region using split thickness flap preparation. - Preparation of the pouch extends in a lateral direction to adjacent teeth and in an apical direction beyond the mucogingival line in order to ensure sufficient flap mobility. -. Flap preparation will also include elevation of the interproximal tissues lateral to the edentulous site. - Vertical releasing incision in the alveolar mucosa apical and distant to the defect will be done. -. The graft will be then drawn using positioning sutures. -. Provisional restoration will be temporary cemented on both abutments then double-crossed sutures are used for the fixation of the buccal soft-tissue complex, including the connective tissue graft. 8. Patient will be recalled after 14 days for suture removal. After the surgical volume augmentation procedure, clinical periodontal measurements will be recorded, impressions will be retaken and models will be cast at 3 and 6 months postoperative, In both control and intervention groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Pontic Site Development With Connective Tissue Graft Using Modified Pouch Technique Versus Pouch Technique: A Randomized Controlled Clinical Trial
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: test group pouch technique
free connective tissue graft augmentation using pouch technique
 Procedure: soft tissue augmentation using pouch technique
crestal incision with split thickness flap without vertical releasing incision till the mucogingival line then apply the harvested connective tissue graft through it.
Experimental: test group modified pouch technique
free connective tissue graft augmentation using modified pouch technique
 Procedure: soft tissue augmentation using modified pouch technique
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 .


Outcome Measures
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Primary Outcome Measures :
  1. volumetric changes at the pontic site [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Postoperative pain - through Visual Analogue Scale [ Time Frame: 14 days ]
    Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain) VAS will be recorded at day 14


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Smokers
  2. Occlusal trauma at site of graft
  3. Pregnancy and lactation
  4. Severe gagging reflex
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ahmed Hassan Abdle Aziz Ammar, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03882216    
Other Study ID Numbers: 5111987
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No