The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation

Soft Tissue Healing Clinical Trial

Official title:

The Effect of Diode Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation in the Esthetic Zone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353999
• Other study ID #: ORG 0008839
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this study was to evaluate clinically the effect of laser photocoagulation in comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft tissue healing during socket preservation with bovine bone xenograft.

Description:

The study was designed as randomized, controlled, clinical trial. patients who were undergoing tooth extraction and socket preservation were divided into two groups: Group I:980 nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of the socket

All patients were clinically and radiographically evaluated at the baseline and on the second , third and fourth weeks postoperatively.Then recalled after 4 months for the final radiographic examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The need for the extraction of nonrestorable maxillary anterior tooth for untreatable caries, endodontic treatment failure or root fracture.

2. Type I postextraction sockets according to the classification proposed by Elian et al. with all bony walls intact .

3. Adult patients (aged 18-50 years).

4. A good standard of oral hygiene, as determined by the registration of an O'Leary Plaque Index of less than or equal to 10% after phase I therapy.

Exclusion Criteria:

1. The presence of any systemic disease that could complicate bone and soft tissue healing of the grafted socket.

2. The presence of any local factor that may interfere with extraction as tooth ankylosis.

3. Smoking.

4. The presence of bone dehiscence and fenestrations of the post-extractive alveolus (Type II and III sockets).

5. Subjects who had undergone radiation therapy.

6. Patients who had been subjected to or who were under bisphosphonate therapy.

Related Conditions & MeSH terms

• Soft Tissue Healing

Intervention

Procedure:
• Socket sealing by diode laser photocoagulation
tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes
• socket sealing with dense polytetrafluroethylene membrane
tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket

Locations

Country	Name	City	State
Egypt	Faculty of dentistry,Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. — View Citation

Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J. 1969 Aug;14(4):241-4. — View Citation

Landry R, Turnbell R, Howley T. Effectiveness of benzydamyne HCl in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988;10:105-118.

Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue healing (the changes in the soft tissue color throughout the first month)	clinical examination and scoring according to Landry healing index. A score of 1 to 5 was given to the surgical site indicating the improvement of the nature of the soft tissue . A score of 1 meaning the least healing and 5 being excellent healing.	at 2nd, 3rd and 4th week
Secondary	soft tissue thickness in millimeters.	The thickness of the soft tissue in the center of the socket was measured at the baseline and after 4 months on the cone beam computed tomoghraph using the ruler tool to measure the thickness in millimeters.	4 months
Secondary	Bone width and height measured in millimeters	bone dimensions were measured on the baseline cone beam computed tomograph and after 4 months also on the recall cone beam computed tomograph.	4 months
Secondary	pain score on the visual analogue scale (VAS)	Pain was measured on the first , forth and seventh day postoperatively. The visual analogue scale comprises a scale graded from 1 to 100 to express the pain on a a ruler the the patient uses to point out the pain score visually with 0 meaning no pain and 100 meaning maximum pain.	1 week